BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP

    MDR report key: 2971554 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01359
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RECURRENT HERNIA OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 MEDWATCH 2210968-2013-01358. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON AN UNKNOWN DATE AND THE MESH WAS FIXATED WITH ABSORBABLE STAPLES. THE PATIENT DEVELOPED A RECURRENT HERNIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77057 SECURESTRAP STAPLES, ABSORBABLE GDW ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention