BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON MESH UNKNOWN

    MDR report key: 16251215 · Received January 26, 2023

    Report

    Report Number
    2210968-2023-00547
    Event Type
    Injury
    Date Received
    January 26, 2023
    Report Date
    January 26, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON AN UNK DATE IN 2008 AND AN UNK MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412327 ETHICON MESH UNKNOWN MESH, SURGICAL, POLYMERIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention