BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MESH UNKNOWN

    MDR report key: 12517556 · Received September 23, 2021

    Report

    Report Number
    2210968-2021-08784
    Event Type
    Injury
    Date Received
    September 23, 2021
    Report Date
    August 24, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE MESH IMPLANT CHANGED THE TRAJECTORY OF THE PATIENT'S HEALTH. IT WAS REPORTED THAT THE PATIENT IS NOW IMMOBILE WITH CHRONIC PAIN, FOREIGN BODY REJECTION, SEVERE NERVE DAMAGE AND A LIFE CONFINED MOSTLY TO THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415212 GYNECARE MESH UNKNOWN MESH, SURGICAL FTM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1