BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 16273637 · Received January 31, 2023

    Report

    Report Number
    3007321028-2022-00056
    Event Type
    Injury
    Date Received
    January 31, 2023
    Report Date
    January 31, 2023
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065093
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF RELEVANT PRODUCTION RECORDS SHOWED NO NON-CONFORMANCES OR ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. HERNIA RECURRENCE AND SEROMA ARE A COMMON KNOWN RISKS OF HERNIA REPAIR WITH OR WITHOUT THE USE OF SURGICAL MESH. PATIENT FACTORS SUCH AS CONCOMITANT SURGERY AND OTHER CO-MORBIDITIES MAY HAVE CONTRIBUTED TO THESE EVENTS. NO KNOWN SURGICAL INTERVENTION HAS BEEN PERFORMED TO ADDRESS THE RECURRENCE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE SEROMA FOLLOWED BY HERNIA RECURRENCE AFTER PARASTOMAL HERNIA REPAIR USING OVITEX 1S PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080945 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY LTD. F10246-1012P ERT-21L03 09421904065093

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other