BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED MEDICAL

    MDR report key: 3212807 · Received July 2, 2013

    Report

    Report Number
    MW5030790
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 23, 2013
    Report Date
    July 2, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING ABDOMINAL SURGERY FOR MASS. REPORTEDLY, DURING THE PROCEDURE, A PIECE OF PLASTIC BROKE OFF ALEXIS 0 WOUND RETRACTOR IN PINK RING. PIECE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300422 APPLIED MEDICAL C-SECTION RETRACTOR 9-14CM LARGE KKX APPLIED MEDICAL 1162106

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR