BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2971504 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01368
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    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). UNSPECIFIED COMPLICATIONS. INADEQUATE FIXATION. 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 2210968-2013-01369. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT DEVELOPED UNSPECIFIED POST-OPERATIVE COMPLICATIONS INCLUDING BRONCHITIS. THE PATIENT UNDERWENT A SECOND PROCEDURE. DURING THE SURGERY IT WAS NOTED THAT THE MESH HAD PULLED AWAY FROM THE ABDOMINAL WALL. IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76156 PHYSIOMESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention