BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP

    MDR report key: 3761309 · Received April 21, 2014

    Report

    Report Number
    2210968-2014-05067
    Event Type
    Injury
    Date Received
    April 21, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    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 A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND STRAPS WERE USED TO FIXATE THE MESH. THE STRAPS TORE THE MESH AND THE PATIENT EXPERIENCED A RECURRENCE OF THE HERNIA. THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239297 SECURESTRAP IMPLANTABLE STAPLE GDW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention