BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 10586181 · Received September 25, 2020

    Report

    Report Number
    2210968-2020-07316
    Event Type
    Injury
    Date Received
    September 25, 2020
    Report Date
    September 24, 2020
    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

    DATE SENT TO THE FDA: 12/17/2020. ADDITIONAL INFORMATION: D4, H4. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 12/16/2020. ADDITIONAL H6 CLINICAL CODE: E231501. ADDITIONAL B5 NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2014 DUE TO RECURRENT VENTRAL HERNIA, ADHESIONS, SEROMA AND SEROUS FLUID. (B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2014. (B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    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 HERNIA REPAIR SURGERY ON (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN UNDISCLOSED ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053317 PHYSIOMESH MESH, SURGICAL FTL ETHICON INC. GB8CQPA0

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention