BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 3220827 · Received July 11, 2013

    Report

    Report Number
    2210968-2013-12720
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 MESH. THE PATIENT HAD TO GO BACK TO THE OPERATING ROOM ON (B)(6) 2013 BECAUSE THE MESH CAME LOOSE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320587 SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE IMPLANTABLE STAPLE GDW ETHICON INC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention