BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PVP MEDIUM 6.4CM X 6.4CM

    MDR report key: 12357176 · Received August 23, 2021

    Report

    Report Number
    2210968-2021-07611
    Event Type
    Injury
    Date Received
    August 23, 2021
    Report Date
    August 20, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    UDI-DI
    10705031132405
    PMA / PMN Number
    K061533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 11/25/2021.

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 10/25/2021.

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 10/29/2021. 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 · 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) 2015 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2019 DURING WHICH THE SURGEON NOTED IT HAD CONTRACTED ALONG THE SUPERIOR RIM OF THE LARGEST DEFECT AND EXCISED THE MESH COMPLETELY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN, NAUSEA, DIARRHEA, CHILLS, INFLAMMATION, LOSS OF APPETITE AND EXTREME WEIGHT LOSS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252395 PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC FTL ETHICON INC. PVPM HL8CSRZ0 10705031132405

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention