REUSABLE GEL PACK, M, 4.5X10.5IN
Received Mar 14, 2017 · Event occurred Feb 28, 2017
Report 1423537-2017-00076 · MDR key 6402346
Device
Generic name
Pack, Hot Or Cold, Reuseable
Manufacturer
Cardinal Health MoberlyModel number
70304Catalog number
70304
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
62 YR
- Superficial (First Degree) Burn
- Superficial (First Degree) Burn
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY REVIEW (DHR) COULD NOT BE COMPLETED AS NO LOT NUMBER WAS AVAILABLE. SINCE NO SAMPLE HAS BEEN RETURNED AT THIS POINT, A FAILURE MODE OR DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE INFORMATION FOR USE (IFU) ON THE PACK INSTRUCTS THE USER TO HEAT THE GEL PACK FOR 55 SECONDS IN A 750 WATT MICROWAVE AND THEN PLACE IN A SLEEVE OR TOWEL. THE WATTAGE OF THE MICROWAVE USED IS NOT KNOWN, HOWEVER, THE PACK WAS PLACED IN A PILLOW CASE INSTEAD OF A TOWEL. A CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME AS THE INFORMATION PROVIDED IS NOT SUFFICIENT TO DETERMINE A DEFINITIVE ROOT CAUSE.
Description of Event or Problem
BASED ON THE INFORMATION PROVIDED BY THE FACILITY THE PATIENT RECEIVED A 1ST DEGREE BURN WHEN THE HOT PACK WAS APPLIED. THE HOT PACK WAS HEATED FOR 1 MINUTE AND WRAPPED IN A PILLOW CASE. THE LEFT LOWER ABDOMEN WAS THE AFFECTED AREA. THE DOCTOR APPLIED A FOAM DRESSING AND THE NEXT DAY REMOVED IT AND APPLIED A TEGADERM FILM DRESSING. PATIENT WAS GIVEN INSTRUCTIONS TO LEAVE THE TEGADERM ON FOR 2 DAYS. NO LOT NUMBER WAS PROVIDED AND THE SAMPLE WAS DISCARDED.