BEUDAMED
    FDA Adverse Event Summary report: N

    PRISM WARM GEL INSTANT HEAT PACK

    MDR report key: 1221684 · Received October 31, 2008

    Report

    Report Number
    1221684
    Date Received
    October 31, 2008
    Date of Event
    July 31, 2008
    Report Date
    October 31, 2008
    Manufacturer
    COOPER SURGICAL
    Product Code
    IMD
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS DISCHARGED FROM THE HOSPITAL VIA AMBULANCE TO A SKILLED NURSING FACILITY. UPON ARRIVAL AT THE SNF, THE PATIENT WAS FOUND TO HAVE WHAT APPEARS TO BE A SECOND DEGREE BURN ON HER LEFT HAND, PALM, WRIST, AND BETWEEN SOME OF HER FINGERS. THERE ALSO IS A BURN ON THE INNER ASPECT OF HER RIGHT WRIST. NO SUCH ASSESSMENT FINDINGS WERE PRESENT WHILE THE PATIENT WAS AT THE HOSPITAL BEFORE SHE WAS DISCHARGED. THE RECEIVING SNF NOTED THAT THE PATIENT'S LEFT LOWER ARM/HAND HAD A PRISM HEAT PACK WITH A GAUZE ROLL HOLDING IT IN PLACE. THE PATIENT'S HUSBAND HAS RETAINED THE DEVICE. PER THE HUSBAND, THE HEAT PACK IS NOT BROKEN AND IS NOT LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM WARM GEL INSTANT HEAT PACK HEAT PACK IMD COOPER SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR LONG-TERM ANTIBIOTICS| OTHER| OTHER| LONG-TERM ANTIBIOTICS