D
Patient 1
CHEMICAL WARM PACK PLACED ON PREMATURE INFANT WITHOUT A PROTECTIVE BARRIER. INFANT SUSTAINED 2ND DEGREE BURN. WARM PACK IS NOT LABELED: "HEAT PACKS SHOULD NOT BE USED ON INFANTS OR PERSONS WITH SENSORY OR CIRCULATORY IMPAIRMENT". THIS STATEMENT IS INCLUDED ON PRODUCT INFORMATION SHEET OBTAINED FROM COMPANY. COMPANY STATES THEY HAVE ANOTHER WARM PACK INTENDED FOR USE ON INFANTSDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, USER EDUCATION PROVIDED. THE DEVICE WAS DESTROYED/DISPOSED OF.