BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP

    MDR report key: 3133994 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-06063
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HERNIA. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-06064. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC IPOM HERNIA REPAIR PROCEDURE ON (B)(6) 2012 AND STRAPS WERE USED TO FIXATE THE MESH. DUE TO A RELAPSE, THE PATIENT UNDERWENT A REOPERATION ON (B)(6) 2012. DURING THE REOPERATION, THE SURGEON NOTED THAT THE PREVIOUS MESH HAD NOT GROWN IN AND IT WAS DETACHED VERY EASILY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236739 SECURESTRAP IMPLANTABLE STAPLE GDW ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention