BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVID ORTHO SPLIT PACK

    MDR report key: 3229907 · Received July 10, 2013

    Report

    Report Number
    MW5030871
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 10, 2013
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    KKX
    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 76" HAD APPEARED AS IF THE DRAPE WAS MELTED, ON THE EDGES, AFTER IT WAS FOLDED. THIS WAS AN ORTHO SPLIT PACK CAT NUMBER: UMDN005-03, LOT NUMBER 887479. DATE OF MFR- 04/01/2013. THIS IS THE SECOND PACK WE RECEIVED WITH A 'MELTED' DRAPE IN IT. OPERATING TABLE HAD TO BE BROKEN DOWN WHICH DELAYED SURGERY. REFERENCE NUMBER: (B)(4). DATE OF USE: (B)(6) 2013. REASON FOR USE: ORTHO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317860 AVID ORTHO SPLIT PACK CUSTOM OPERATING ROOM PACK KKX AVID MEDICAL, INC. UMDN005-03 887479
    317861 DRAPE DRAPE KKX KIMBERLY CLARK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other