BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 19968958 · Received August 12, 2024

    Report

    Report Number
    3007321028-2024-00055
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    July 4, 2024
    Report Date
    August 12, 2024
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065093
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AROA'S REVIEW OF MANUFACTURING DOCUMENTATION FOR THE SUBJECT LOT (ERT-23H17) HAS CONFIRMED THAT THE DEVICES WERE PRODUCED IN ACCORDANCE WITH THE ESTABLISHED PROCEDURES. ALL PROCESS SPECIFICATIONS AND FINAL RELEASE SPECIFICATIONS WERE SATISFIED. ADHESION, BOWEL OBSTRUCTION, AND INFECTION ARE NOTED AS POTENTIAL COMPLICATIONS IN THE INSTRUCTIONS FOR USE OF THE DEVICE. THERE WAS NO EVIDENCE TO INDICATE THAT THE DEVICE DIRECTLY CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE INFECTION AND BOWEL OBSTRUCTION. THE LATTER LED TO BOWEL OBSTRUCTIVE SYMPTOMS AND RE-OPERATION WHERE ADHESIONS WERE NOTED. THE DEVICE WAS REMOVED AFTER ADHESIONS WERE FREED. THERE WAS NO REPORTED PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205850 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY LTD. F10246-1012P ERT-23H17 09421904065093

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| R