BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAB SPONGE 18X18

    MDR report key: 5369687 · Received January 12, 2016

    Report

    Report Number
    MW5059356
    Event Type
    Malfunction
    Date Received
    January 12, 2016
    Date of Event
    January 8, 2016
    Report Date
    January 12, 2016
    Manufacturer
    ALLCARE, INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    USING ALLCARE PRODUCT (B)(4) LAP SPONGE, SPONGE WAS SHEDDING FABRIC INTO THE SURGICAL WOUND, REQUIRING EXTRA ATTENTION TO INSURE THAT ALL PARTICLES WERE REMOVED FROM WOUND PRIOR TO CLOSURE. DIAGNOSIS OR REASON FOR USE: LAP SPONGE USED FOR ABSORPTION OF BLOOD AND WOUND EXUDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20128 LAB SPONGE 18X18 GDY ALLCARE, INC. AL1818 210J02

    Patients

    Seq Age Sex Outcome Treatment
    1