BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE SOFT POLYPROPYLENE MESH

    MDR report key: 1980088 · Received January 31, 2011

    Report

    Report Number
    MW5019253
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 10, 2010
    Report Date
    January 31, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STAFF WERE USING ETHICON'S PROLENE MESH AND DID NOT SEE THE SMALL EXP DATE ON THE OUTER PACKAGING. ADDITIONALLY, THE LIFT OFF STICKER THAT BECOMES PART OF THE PERMANENT MEDICAL RECORD - DID NOT EVEN CONTAIN AN EXP DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE SOFT POLYPROPYLENE MESH IMPLANTABLE MESH FTL ETHICON 0G P919

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization