BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 11721963 · Received April 25, 2021

    Report

    Report Number
    2210968-2021-03752
    Event Type
    Injury
    Date Received
    April 25, 2021
    Report Date
    April 20, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 11/25/2021. 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: 11/16/2021. ADDITIONAL B5 NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT INCISIONAL HERNIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/25/2021. (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 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
    618161 PHYSIOMESH MESH, SURGICAL FTL ETHICON INC. GJ8GMPA0

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention