BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYPRO-MESH II

    MDR report key: 3181092 · Received June 20, 2013

    Report

    Report Number
    2210968-2013-10689
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K002672
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL FOIL WITH THE IMPLANT WAS RETURNED FOR EVALUATION. THE FOIL WAS OPENED COMPLETELY WHICH SHOWS A MULTITUDE OF WRINKLES OVER THE WHOLE BOTTOM OF THE POUCH. THE HOLE (APPROX. 0.3CM) IS LOCATED IN A FOLD/KINK IN THE MIDDLE OF THE FOIL. THE IMPLANT ITSELF SHOWS NO DEFECTS (NO DEGRADATION). THE HOLE WAS SEEMINGLY CAUSED BY HANDLING OF THE CUSTOMER (DURING OPENING). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR IN SUBLY TECHNIQUE ON AN UNKNOWN DATE AND MESH WAS USED. THE PAPER PACKAGING WAS FINE, BUT AFTER TAKING OFF THE PACKAGING THE FOIL CONTAINING THE MESH HAD A HOLE IN THE BACK, CLOSE TO THE LOT NUMBER STICKER. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER LIKE DEVICE WAS USED WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280030 VYPRO-MESH II MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK EJ8GPPQ0

    Patients

    Seq Age Sex Outcome Treatment
    1