BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAPE, SURGICAL

    MDR report key: 4445397 · Received June 9, 2014

    Report

    Report Number
    1030451-2014-00005
    Event Type
    Other
    Date Received
    June 9, 2014
    Product Code
    KKX
    Report Source
    Distributor report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT A SURGICAL DRAPE AS INDICATED, ON THE ATTACHED MEDWATCH REPORT, BUT IS RATHER AN OPERATING ROOM TOWEL (PRODUCT CODE KKX FOR "DRAPE, SURGICAL"). MAI PURCHASES DEVICE FROM (B)(4). ON 05/13/2014, MAI RECEIVED THE ATTACHED MEDWATCH (B)(4) FROM FDA AND IMMEDIATELY OPENED COMPLAINT #(B)(4) AND BEGAN THE INVESTIGATION. UNFORTUNATELY, THE CUSTOMER HAD THE SAMPLE, BUT INADVERTENTLY SENT IT TO ANOTHER MFR, THEREBY LIMITING OUR INVESTIGATION. CURRENTLY, INVENTORY OF THE COMPLAINT LOT HAS BEEN EXHAUSTED. SAMPLES FROM OTHER LOTS WERE EXAMINED WITH NO FAILURES. ALTHOUGH NO CONCLUSION COULD BE DRAWN FROM THE INVESTIGATION, WE SPECULATE THE TEAR WAS MOST LIKELY CAUSED BY MISHANDLING DURING THE PACKAGING PROCESS AND THEN MISSED DURING THE FINAL INSPECTION PROCESS. THIS IS THE FIRST COMPLAINT OF THIS NATURE FOR THIS ITEM. ALL TEAM MEMBERS RESPONSIBLE FOR THIS PRODUCT LINE, INCLUDING OUR SUPPLIER, HAVE BEEN NOTIFIED OF THIS COMPLAINT.

    Description of Event or Problem · 1

    REF UF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337159 DRAPE, SURGICAL DRAPE, SURGICAL KKX

    Patients

    Seq Age Sex Outcome Treatment
    1