REUS INSUL GEL PK JUMBO

Description of Event or Problem

THE PATIENT'S BACK WAS HURTING AFTER BEING GIVEN AN EPIDURAL, SO THE NURSE APPLIED A HEATED GEL PAC4 TO THE PATIENT'S BACK. THE PATIENT SUFFERED A BURN ON HER BACK FROM THE PACK, AND WAS LATER DISCHARGED FROM MATERNITY TO THE WOUND CLINIC. THE HOSPITAL HAS TAKEN PHOTOS OF THE BURN, WHICH IS SAID TO BE STANDARD PROCEDURE FOR PATIENTS ENTERING THE WOUND CLINIC. THE LOT #V8N237 WAS PULLED AND IS BEING KEPT IN DONNA'S OFFICE.

Additional Manufacturer Narrative

A SAMPLE FROM LOT V8N237 WAS RECEIVED ON 2/19/09. THIS SAMPLE WAS INSPECTED AND SUBMITTED TO A BATTERY OF TESTS. THE TESTS REVEALED THAT THE PRODUCT PERFORMED AS EXPECTED. NO LEAKS OR DEFICIENCIES IN THE SEALS WERE NOTED. LABEL COPY ON THE PACK WAS STILL CLEARLY VISIBLE AND UNCHANGED. THE PHYSICAL TESTING CONSISTED OF SUBMITTING THE SAMPLE TO A PROTOCOL OF HEATING VIA A 750 WATT MICROWAVE AS PER LABEL COPY DIRECTIONS AND A 1200 WATT MICROWAVE AND THEN MEASURING THE RESULTS WITH A CALIBRATED INSTRUMENT. AFTER HEATING THE GEL PACK USING A 750 WATT MICROWAVE, PER INSTRUCTION ON THE POUCH, THE WARMEST TEMPERATURE AFTER 20 MINUTES ON THE TEMPERATURE RECORDER WAS 111.8 DEGREES F, THIS WAS ONLY ONE PROBE. AFTER HEATING THE GEL PACK USING A 1200 WATT MICROWAVE FOR 240 SECONDS, ALL TEMPERATURE PROBES WERE BETWEEN 125.5 DEGREES F AND 141.3 DEGREES F. THE INVESTIGATOR ALSO REQUESTED THE COMPLAINANT TO PROVIDE ADDITIONAL INFORMATION, NAMELY THE WATTAGE OF THE MICROWAVE USED WHEN THE INCIDENT OCCURRED. PHONE CALLS TO OBTAIN THIS INFORMATION WERE MADE AS FOLLOWS: (B) (6) 2009 AT 9:30, 11:00, 1PM, 2:30 PM AND 4PM. ON (B) (6)2009 AT 8:30, 9:43, 11:15, 2PM AND 3PM. ON (B) (6)2009 AT 8:40 AM, THE INVESTIGATOR REACHED THE COMPLAINANT AND THE COMPLAINANT INDICATED THAT THE MICROWAVE USED WAS A SHARP CAROUSEL R-410, (B) (4), OUTPUT 1.00W/120VOLT/65KW/1100 WATTS.