inforMED
MalfunctionIME

ALDI WELBY GEL PACK

Received Jun 13, 2016 · Event occurred Mar 28, 2016

Report 1422443-2016-00004 · MDR key 5721057

Device

Generic name

Aldi Welby Gel Pack

Model number

17-0060-9824

Catalog number

17-0060-9824

Lot number

NI

Product problems

  • Improper or Incorrect Procedure or Method
  • Improper or Incorrect Procedure or Method

Patient

47 YR

  • Burn, Thermal
  • Partial thickness (Second Degree) Burn
  • Burn, Thermal
  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

END USER STATED SHE FELL ASLEEP IN A RECLINER WITH THE GEL PACK ON HER LOWER BACK WITH A TOWEL FOR ABOUT AN HOUR AND WOKE UP WITH SECOND DEGREE BURNS (FROSTBITE). END USER WENT TO THE EMERGENCY ROOM, WHERE SHE WAS GIVEN LIDOCAINE, BURN CREAM AND AN ANTIBIOTIC. SHE HAS BEEN USING THE PRODUCT FOR MORE THAN 2 YEARS. PER PRODUCT PACKAGING (921-0060-98240 04/07), "DO NOT USE FOR MORE THAN 30 MINUTES. EXTREME COLD CAUSES FROSTBITE. WRAP BAG WITH THICK DRY OR MOIST TOWEL TO OBTAIN MEASURED HEATING OR COOLING EFFECT". THE END USER USED THE PRODUCT FOR LONGER THAN REQUIRED.