BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAPRO HERNIA PLUG

    MDR report key: 3073005 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04318
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    PMA / PMN Number
    K070224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE DEVICE MET PERFORMANCE SPECIFICATIONS. THE SAMPLE SHOWS A TORN FOIL ON ONE SIDE AT THE CORNER. IT SEEMS THAT THE FLAPS WERE GRASPED ONLY AT ONE CORNER. THE SEAL STRENGTH AT THREE STILL CLOSED SIDES OF THE FOIL WAS TESTED AND MEET THE REQUIREMENTS. ACCORDING TO THE IFU, THE FOIL SHOULD BE OPENED BY GRASPING THE FLAPS IN THE MIDDLE (EACH FLAP IN ONE HAND) AND THEN PULLING DOWNWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. DURING THE PROCEDURE IT WAS NOTED THAT THE PACKAGING WAS TORN ALONG THE BACK CENTER AND THE STERILITY APPEARED TO BE COMPROMISED. A SECOND DEVICE WAS USED AND THE CASE WAS COMPLETED. THE PRODUCT WAS NOT USED ON THE PATIENT, THEREFORE THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175446 ULTRAPRO HERNIA PLUG MESH, SURGICAL FTL ETHICON, INC NA EG8GQZA0

    Patients

    Seq Age Sex Outcome Treatment
    1