BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELECT MEDICAL PRODUCT INSTANT HEAT COMPRESS

    MDR report key: 1813630 · Received August 13, 2010

    Report

    Report Number
    9710505-2010-00002
    Event Type
    Other
    Date Received
    August 13, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 6, 2010
    Manufacturer
    RAPID AID CORP
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEAT PACK WAS ACTIVATED BY A HEALTHCARE WORKER AND WRAPPED IN A TOWEL. THE PATIENT REMOVED THE TOWEL AS THE PRODUCT INSTRUCTIONS INDICATE THAT A TOWEL IS NOT REQUIRED. AS A RESULT, THE PATIENT SUSTAINED A FIRST DEGREE BURN. A REVIEW OF THE MANUFACTURING INFORMATION FOR THIS HEAT COMPRESS SKU 3083 LOT RA09320A FINDS THAT DURING THE FILL, THERE WAS AN OVERFILL OF CHEMICAL IN THE PRODUCT. THE ISSUES AFFECTING THE OVERFILL OF CHEMICAL ARE BEING ADDRESSED IN THE MANUFACTURING FACILITY THROUGH THE PURCHASE OF SUPPLEMENTAL MONITORING EQUIPMENT AND CORRESPONDING TRAINING ON THIS MONITORING EQUIPMENT. AT THIS TIME, THE FREQUENCY OF CHECKS HAS BEEN INCREASED UNTIL THE REMAINING ACTIVITIES HAVE BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HEALTHCARE CENTER STATES THAT THE HEALTHCARE WORKER AT THE FACILITY WRAPPED A 3083 INSTANT HEAT COMPRESS LOT RA09320A IN A TOWEL AND APPLIED THIS TO THE BUTTOCKS OF A PATIENT. THE PATIENT REMOVED THE HOT PACK AS THE INSTRUCTIONS INDICATE A TOWEL IS NOT REQUIRED. THE PATIENT SUBSEQUENTLY RECEIVED A FIRST DEGREE BURN ON THEIR BUTTOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT MEDICAL PRODUCT INSTANT HEAT COMPRESS HOT OR COLD DISPOSABLE PACK IMD RAPID AID CORP 3083 RAO9320A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other