BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVID NEURO TRAY

    MDR report key: 3229883 · Received July 10, 2013

    Report

    Report Number
    MW5030874
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 10, 2013
    Manufacturer
    AVID MEDICAL INC.
    Product Code
    LRO
    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 (B)(4), CONTAINING KIMBERLY CLARK DRAPES. KC XL DRAPE 135 100" X 76" HAD TEARS IN IT THAT APPEARED AS IF THE DRAPE WAS MELTED. THIS WAS A NEURO PACK CAT NUMBER UMDN007-03, LOT NUMBER: 893517. DATE OF MFR: 05/01/2013. THIS IS THE THIRD PACK WE RECEIVED WITH A 'MELTED' DRAPE IN IT. OPERATING ROOM TABLE HAD TO BE BROKEN DOWN WHICH DELAYED SURGERY. (B)(4). DATES OF USE: (B)(6) 2013. REASON FOR USE: NEURO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316150 AVID NEURO TRAY CUSTOM OR PACK LRO AVID MEDICAL INC. UMDN007-03 893517
    316151 DRAPE DRAPE KKX KIMBERLY CLARK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other