BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE* POLYPROPYLENE MESH

    MDR report key: 8200972 · Received December 27, 2018

    Report

    Report Number
    2210968-2018-78061
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    December 5, 2018
    Report Date
    December 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    UDI-DI
    10705031049031
    PMA / PMN Number
    K962530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 02/14/2019. ADDITIONAL: PML LOT V8002 RECEIVED IN OPENED CONDITION. ACTUAL SAMPLE CONSISTED OF 1 OPENED FOLDER WITH MESH AND SBF. TAMPER PROOF STICKERS WERE CHECKED AND FOUND PEELED-OFF AT THE TIME OF OPENING. RETAINED SAMPLES OF THE INCIDENT CODE AND LOT WAS RETRIEVED FOR VISUAL INSPECTION. THE PRIMARY FOLDER OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR PRESENCE OF DESIRED PACK COMPONENTS AND FOUND SATISFACTORY. ALL THE RETAIN SAMPLES WERE VISUALLY CHECKED FOR PACKAGE INTEGRITY AND OBSERVED SEALED FROM ALL SIDES. SEAL STRENGTH REPORTS AT THE TIME OF RELEASE WERE CHECKED AND RESULTS WERE WITHIN THE SPECIFICATION LIMITS. THIS IS ONE AND ISOLATED CASE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND MESH WAS USED. AFTER OPENING THE BOX, THE SECONDARY PACKAGING WAS FOUND OPEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039907 PROLENE* POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. V8002 10705031049031

    Patients

    Seq Age Sex Outcome Treatment
    1