BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL HOT/COLD PACK, 4.5IN X 9.5IN, 20/CS

    MDR report key: 4009150 · Received July 14, 2014

    Report

    Report Number
    1123071-2014-00016
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 11, 2014
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    IMD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: NO SAMPLE WAS RETURNED. DURING A REVIEW OF THE INFORMATION LISTED IN THIS QFI, I FOUND THAT THE PRODUCT WAS BEING PURCHASED FROM A DISTRIBUTOR. WITH THAT BEING SAID, I REVIEWED THE ROUTING OF THE PRODUCT - FIRST THE RAW MATERIALS ARE PULLED AT THE FAB FACILITY AND SHIPPED TO (B)(4). AT (B)(4) THE PACKS ARE COUNTED OUT AND 20 ARE PACKAGED/LABELED THEN SHIPPED (B)(6). ONCE THE ORDER IS PLACED THE FINISHED GOOD IS PULLED/BILLED AND SHIPPED TO, IN THIS CASE CARDINAL. CARDINAL GETS AN ORDER AND SHIPS THE PRODUCT TO THE FACILITY THAT IS FILING THE COMPLAINT. THE FACILITY IS THEN PLACING THE PRODUCT ON SHELVES IN A FREEZER, BEFORE IT IS PLACED ON THE PATIENT. THESE ITEMS ARE BRIGHT BLUE IN COLOR ANY LEAKS SHOULD BE QUITE EASILY SEEN DURING HANDLING. WE ARE UNSURE IF THE PRODUCT WAS DAMAGED PRIOR TO HAVING BEEN USED. THE VENDOR WAS INFORMED ABOUT THE ISSUES AND REQUESTED SAMPLES, HOWEVER, WE WERE UNABLE TO PROVIDE ANY. THEY ARE UNWILLING TO TAKE RESPONSIBILITY FOR THE DAMAGED PACKS AS THERE WERE NO ISSUES FOUND DURING DEROYAL HANDLING/REVIEW. WE WILL BE GETTING FUTURE ORDERS FROM OUR OLD VENDOR AS THE FACILITY HAS BEEN REOPENED. CORRECTION: REPLACEMENT SENT. ROOT CAUSE ANALYSIS: POSSIBLE ENDUSER ISSUES. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: NO FURTHER ACTION IS REQUIRED AS NO VENDOR DEFECT/ERROR COULD BE FOUND.

    Description of Event or Problem · 1

    THE ICE PACKS ARE NOT ONLY LEAKING BUT THE HOLES THESE ARE DEVELOPING ARE 1/4" OR BIGGER. THESE ICE PACKS ARE SPILLING OUT ONTO THE PATIENT, GETTING THE DRESSING SOAKED, AND EVEN GETTING NEAR OR ON THE PATIENT'S WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410201 DEROYAL HOT/COLD PACK, 4.5IN X 9.5IN, 20/CS PACK, HOT OR COLD, DISPOSABLE IMD DEROYAL INDUSTRIES MH73912

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention