BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECT MEDICAL PRODUCTS; INSTANT ICE COMPRESS

    MDR report key: 1934752 · Received November 26, 2010

    Report

    Report Number
    9710505-2010-00003
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Report Date
    November 13, 2010
    Manufacturer
    RAPID AID CORP.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RAPID AID LABELING CLEARLY STATES THIS PRODUCT IS FOR ONE-TIME USE ONLY. THE PATIENT STATES SHE REUSED HER DISPOSABLE COLD PACK. THIS TYPE OF USAGE IS CONSIDERED OFF LABEL USE OR MISUSE BY THE CUSTOMER. THIS IS CONSIDERED A FINAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT STATES SHE RE-USED HER SINGLE USE DISPOSABLE COLD PACK. UPON REUSE, THE BAG BURST AND SATURATED HER CLOTHING WITH ITS CONTENTS. THE PATIENT EXPERIENCED RED AND BLISTERING SKIN ON HER BACK, WHERE THE PACK CONTENTS MADE CONTACT. SHE WAS DIRECTED TO SEEK MEDICAL ATTENTION. THE RAPID AID LABELING CLEARLY STATES THIS PRODUCT IS A ONE-TIME USE ONLY. THIS TYPE OF USAGE IS CONSIDERED OFF LABEL USE OR MISUSE BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT MEDICAL PRODUCTS; INSTANT ICE COMPRESS INSTANT COLD PACK IMD RAPID AID CORP. 3088 RA10204A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other