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serious injury 98 articles

Cardiac device recalled due to risk of serious injury, death

A device used to block off the aorta, monitor aortic pressure, and deliver solution to stop the heart during cardiopulmonary bypass procedures has been recalled by the Food and Drug Administration (FDA) because the device’s balloon catheters may spontaneously rupture during surgery and may result in serious health consequences or death to patients. The Class 1 recall includes model numbers EC1001 and EC65 of CardioVations EndoClamp Aortic Catheters manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009. A Class 1 recall is the most serious type of recall the FDA can issue and involves situations ... Read More

Concussions in children require extra care and attention

Concussions, injuries that fall on the mild side of the traumatic brain injury (TBI) scale, are receiving significantly more consideration these days than ever before, thanks to studies that probe and attempt to grasp the often elusive nature of TBI. TBI has worked its way into the public awareness recently, shepherded by reports of record numbers of soldiers returning from the Middle East with brain injuries, considered the “signature injury” of the Iraq and Afghanistan wars, and the head injuries of high-profile people such as Natasha Richardson. As more and more Americans deal with the repercussions of TBI in themselves ... Read More

Defective cords on medical devices may cause serious injury, death

The Food and Drug Administration (FDA) is investigating certain types of medical devices made by Hospira Inc. and Abbott Nutrition after 122 reports of sparking, charring and fires from the power cords used with the devices. The announcement follows a recall announcement and FDA warning last August on some medical devices made by Hospira Inc. because of faulty electrical cords that could lead to serious injury or death. The companies’ investigations of these reports determined that the power cords prongs may crack and fail at or inside the plug. The potential risks from these power cord failures include electrical shock, ... Read More

Infusion pump catheters recalled due to risk of serious injury, death

A catheter that connects to infusion pumps used to store and deliver medicine into the body is being recalled because its design is incompatible with certain pumps and may cause serious injury or death due to catheter disconnection or blockage at the connection site. The Class I recall was announced this week by the Food and Drug Association (FDA) and covers INDURA 1P Intrathecal Catheter model 8709SC, Intrathecal Catheter, model 8731SC; Sutureless Pump Connector Revision Kit, model 8578; and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. A Class I recall is the most serious type of recall the FDA ... Read More

TBI kills UC San Diego pole vaulter

A 19-year-old pole vaulter for the University of Southern California San Diego died earlier this month after receiving a traumatic brain injury. According to the Los Angeles Times, sophomore Leon Roach from Huntington Beach, California, had been practicing his vaults on Thursday, September 3. Roach was completing a jump but missed the pads and hit the concrete instead, landing head first. According to the Los Angeles Times, the accident happened around 7:19 p.m. during a routine rope swing drill at the UC San Diego campus. Reports say that Roach was unresponsive and stopped breathing immediately after the accident occurred. He ... Read More

Research helps identify injured children at low risk of TBI

Your 18-month toddler chases after a ball and hits her head on the edge of a table, knocking her to the ground. A softball hits your 12-year old athlete in the head, leaving a noticeable welt. Both of these seem like minor, albeit painful injuries, but you’ve seen reports on television and online that some seemingly innocuous bumps and minor concussions can lead to a deadly traumatic brain injury. What should you do? Time, money, and x-ray radiation considered, it would be both unhealthy and nearly impossible to rush one’s children to the hospital for a CT scan every time ... Read More

Surgical drills, blades, shavers self-activate spurring Class 1 recall

The Food and Drug Administration (FDA) has issued a Class 1 recall on a type of surgical drills, blades and bone and cutting devices because the tools can unintentionally self-activate and move in unintended directions. A Class 1 recall is the most serious type of recall and involves situations in which there is a reasonable probability that the use of the products will cause serious injury or death. The recall, spurred by reports of a switch problem,  involves two ConMed Linvatec surgical service products. Self-activation in some circumstances cause injury, although ConMed has not received reports of injuries to patients. ... Read More

Firms fined $610,000 for selling hazardous children’s clothing

Four firms have been ordered to pay a total of $610,000 in civil penalties for knowingly failing to immediately report to the U.S. Consumer Product Safety Commission (CPSC), as required by federal law, that children’s hooded sweatshirts or jackets they sold had drawstrings at the neck. The drawstrings on children’s upper outerwear, including sweatshirts or jackets, pose a strangulation hazard to children that can result in serious injury or death. The CPSC and the firms have announced recalls on the products. Maran Inc. of North Bergen, N.J., and K.S. Trading Corp., of Moonachie, N.J., were fined a total of $85,000. ... Read More

FDA sends warning about glucose test strips

The Food and Drug Administration (FDA) is issuing a warning to diabetes health care professionals, hospital risk managers and patients about a brand of glucose test strips that may falsely report elevated blood glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose and galactose, are found in certain drug and biologic formulas, or can result from the metabolism of a drug or therapeutic product. The FDA ... Read More

FDA recalls infusion pumps; risk of serious injury, death

Electronic infusion pumps that deliver controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural and other routes of administration are being pulled from the market after the Food and Drug Administration (FDA) issued a Class 1 recall on the products. A Class 1 recall is the most serious type of recall and involves situations in which there is reasonable probability that the use of the products will cause serious injury or death. The recall includes various modules of Cardinal Health’s Alaris System products that are intended for use with both adult and pediatric patients in ... Read More