BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTANT ICE COMPRESS

    MDR report key: 2113868 · Received May 18, 2011

    Report

    Report Number
    9710505-2011-00005
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    March 31, 2011
    Manufacturer
    RAPID AID CORP
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT LOT WAS MANUFACTURED NOVEMBER 2010 WHERE IT WAS SUBJECTED TO OVER 69 IN PROCESS CHECKS WHICH INVOLVED THE ACTIVATION OF THE UNIT AND SUBSEQUENT PRESSURE TEST TO ENSURE NO PRODUCT LEAKAGE. ALL PRESSURE CHECKS DOCUMENT THAT THE INTEGRITY OF THE BAG WAS MAINTAINED FOLLOWING ACTIVATION AND THERE WAS NO NOTATION REGARDING THE POUCH MATERIAL BURSTING. A REVIEW OF COMPLAINTS OF THIS NATURE FOR OTHER PRODUCTS FINDS NO ADDITIONAL COMPLAINTS RECEIVED FOR BURSTING PRODUCT FOLLOWING ACTIVATION. THE SEALS (TOP, BOTTOM, BACK) OF THREE RETAIN SAMPLES OF INSTANT COLD PACK (B)(4) WERE REVIEWED AND DID NOT NOTICE ANY WEAK SEALS OR SIGNS OF POSSIBLE LEAKAGE. BASED ON A REVIEW OF THIS ISSUE IT WAS DETERMINED THAT NONE OF THE UNITS DURING MANUFACTURE BURST WHEN ACTIVATED. RAPID AID WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE. WE HAVE NOT BEEN ABLE TO GATHER ADDITIONAL INFORMATION. THIS IS CONSIDERED A FINAL REPORT.

    Description of Event or Problem · 1

    PSS INSTANT ICE COMPRESS BURST UPON ACTIVATION AND SPLASHED IN A HEALTH CARE WORKER'S FACE. HEALTH CARE WORKER DIDN'T NEED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTANT ICE COMPRESS IMD RAPID AID CORP 3081 RA10328CAN

    Patients

    Seq Age Sex Outcome Treatment
    1