CARDINAL HEALTH INSULATED GEL PACK
Received Jun 22, 2023 · Event occurred May 26, 2023
Report 17181232 · MDR key 17181232
Device
Generic name
Pack, Hot Or Cold, Reusable
Manufacturer
Cardinal Health 200, LlcProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Erythema
- Unspecified Infection
- Full thickness (Third Degree) Burn
- Blister
- Erythema
- Unspecified Infection
- Full thickness (Third Degree) Burn
- Blister
Narrative
Description of Event or Problem
PATIENT S/P (STATUS POST) TOTAL ABDOMINAL HYSTERECTOMY (HAD BLOCK W/ MARCAINE & EXPAREL PRE-OP). A HEAT PACK WAS USED POST-OP FOR CRAMPING & ABDOMINAL PAIN. A SMALL BLISTERED AREA NOTED AT INCISION W/ SURROUNDING ERYTHEMA. PT RETURNED TO HOSPITAL W/ CONCERN FOR BURN AT INCISION SITE & INFECTION. SHE REQUIRED ADMISSION, PLASTIC SURGERY CONSULT, AND 2 ADDITIONAL PROCEDURES W/ XENOGRAFT PLACEMENT. PT DID REPORT SHE USED HEAT ON HER ABDOMEN AFTER DISCHARGE - UNABLE TO DETERMINE TYPE OF HEATING PACK USED. INVESTIGATION RESULTS: 1) NURSING REPORTED HEATING PACK WAS USED PER MANUFACTURER GUIDELINES AND PLACED ABOVE THE BINDER. 2) UNABLE TO FULLY VERIFY IF BLOCK WAS STILL EFFECTIVE AT THE START OF HEATING PACK USE. 3) ASSESSMENT OF SITE CONSISTENT WITH A BURN - CONCERN NOTED D/T CONSISTENT USE OF HEAT PACK DURING HOSPITALIZATION. 4) MANUFACTURER IFU INCLUDES PLACING PACK IN WRAP - NURSING REPORTS THIS WAS DONE. 5) MANUFACTURER IFU NOTES MICROWAVE AT 750 WATTS. INVESTIGATION ON MICROWAVE USED TO HEAT IS 700 WATTS.