BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSIOMESH RECTANGULAR

    MDR report key: 3202361 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11894
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE PACKAGE SHOWS A MULTITUDE OF WRINKLES OVER THE WHOLE OPENED POUCH AREA. THE HOLE IS LOCATED IN THE MIDDLE OF THE OPENED FOIL. THE IMPLANT ITSELF SHOWS NO DEFECTS. 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). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. WHEN THE DEVICE WAS OPENED IT WAS NOTED THAT THERE WAS A HOLE IN THE INNER PACKAGE. A SECOND DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300922 PHYSIOMESH RECTANGULAR MESH FTL ETHICON INC. UNK EJ8KKSA1

    Patients

    Seq Age Sex Outcome Treatment
    1