BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELECT MEDICAL PRODUCT INSTANT HEAT COMPRESS

    MDR report key: 1813632 · Received August 13, 2010

    Report

    Report Number
    9710505-2010-00001
    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 Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MFR DATE: 08/2009. THE HEAT PACK THAT WAS ACTIVATED AND APPLIED TO A PATIENT'S SHOULDER AND NOT RETURNED FOR EVALUATION. AN EVALUATION OF UNITS FROM ONE OF THE SUSPECTED LOTS DID FIND SOME UNITS OF PRODUCT THAT EXCEEDED THE REQUIRED FILL AMOUNT OF THE ACTIVE CHEMICAL. BASED ON THE INFORMATION FROM THE NURSING FACILITY THE HEAT PACK WAS ACTIVATED BY AN EMPLOYEE AT THE FACILITY AND LEFT ON THE PATIENT'S RIGHT SHOULDER. IT IS NOT CLEAR IF THE PATIENT WAS INCAPACITATED WHEN THE PRODUCT WAS USED, HOW LONG THE DEVICE WAS ON THE SHOULDER OR IF THE DEVICE WAS FIXED IN PLACE DIRECTLY ON THE SHOULDER. PRODUCT LABELING DOES INDICATE THAT THE USE OF THE DEVICE BY INCAPACITATED INDIVIDUALS IS DANGEROUS. 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.

    Description of Event or Problem · 1

    (B)(6), RN REPORTED THIS EVENT TO (B)(6) MEDICAL. A 3083 INSTANT HEAT COMPRESS WAS ACTIVATED BY AN EMPLOYEE OF THE (B)(6) NURSING FACILITY AND APPLIED TO RESIDENT'S RIGHT BACK SHOULDER. ACCORDING TO A RN AT THE FACILITY, IT IS UNKNOWN HOW LONG THE INSTANT HEAT APPLIED, BUT IT RESULTED IN FIRST DEGREE BURN ON THE RIGHT POSTERIOR SHOULDER OF A (B)(6) YEAR OLD MOBILE RESIDENT. PATIENT WAS NOT SEEN BY A PHYSICIAN, BUT A DRESSING WAS APPLIED AND CHANGED 48 HOURS LATER.

    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 RAO9321A/RAO9243A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other