BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVID

    MDR report key: 3229903 · Received July 10, 2013

    Report

    Report Number
    MW5030869
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    July 10, 2013
    Manufacturer
    AVID MEDICAL INC.
    Product Code
    KDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM CUSTOM PACK MANUFACTURED BY AVID, SOLD VIA MEDICAL ACTION, CONTAINING KIMBERLY CLARK DRAPES. KC XL DRAPE 135 100" X 77" 502394 HAD METAL SHAVINGS, DUST PARTICLES AND AN UNCONFIRMED SUBSTANCE THAT APPEARED TO BE OIL IN THE DRAPE. THIS DRAPE ALSO HAD A LARGE TEAR HOLE IN IT. THIS WAS AN ORTHO SPLIT PACK CATALOG NUMBER: UMDN005-03 LOT NUMBER: 887478. THIS IS THE FIRST OF THREE PACKS WE RECEIVED WITH A 'MELTED' DRAPE IN IT. OPERATING ROOM TABLE HAD TO BE BROKEN DOWN WHICH DELAYED SURGERY. ALSO SEE MW517296 AND MW51295.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315357 AVID CUSTOM OPERATING ROOM PACK KDD AVID MEDICAL INC. UMDN005-03 887478
    315358 KIMBERLY CLARK DRAPES KC XL DRAPE 135 100C77 KKX KIMBERLY CLARK UMDN005-03 502394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other