BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 8761300 · Received July 3, 2019

    Report

    Report Number
    2210968-2019-83616
    Event Type
    Injury
    Date Received
    July 3, 2019
    Report Date
    October 16, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT PROBLEM AND EVALUATION CODES: 2240, 2422,1994, 3189 - SURGICAL INTERVENTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2014 DUE TO HERNIA RECURRENCE, SMALL BOWEL OBSTRUCTION AND PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. THE PATIENT HAD A PREVIOUS MESH IMPLANTED ON (B)(6) 2013. OTHER IMPACTED PRODUCT IS CAPTURED UNDER A SEPARATE FILE. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552758 PHYSIOMESH MESH, SURGICAL FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention