BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL

    MDR report key: 10015088 · Received April 30, 2020

    Report

    Report Number
    2210968-2020-03626
    Event Type
    Injury
    Date Received
    April 30, 2020
    Report Date
    April 29, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO FDA: 6/25/2020. CORRECTED INFORMATION: A2.

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 12/10/2020. 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 FDA: 06/25/2020. ADDITIONAL INFORMATION: A1, A2, A4, B7, D1, D2, D4, D7. H6 PATIENT CODE: 3189 - SURGICAL INTERVENTION. ADDITIONAL B5 NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO RECURRENT VENTRAL INCISIONAL HERNIA AND LYSIS OF ADHESIONS.

    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 A HERNIA REPAIR PROCEDURE ON (B)(6) 2011 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
    478332 ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL MESH, SURGICAL FTL ETHICON INC. DB8KPPA0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention