BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 17401704 · Received July 26, 2023

    Report

    Report Number
    3007321028-2023-00020
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 19, 2023
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065130
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HERNIA RECURRENCE AND ADHESIONS ARE KNOWN RISKS ASSOCIATED WITH ABDOMINAL/HERNIA SURGERY, AS NOTED IN THE ACCOMPANYING LABELING. A REVIEW OF THE RELEVANT BATCH RECORD SHOWED NO NON-CONFORMANCES OR ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2022. OVITEX 1S WAS PLACED AS AN UNDERLAY REINFORCEMENT, SUTURED WITH INTERRUPTED SUTURES AND THE FASCIA AND SKIN CLOSED. THE PATIENT RETURNED TO OFFICE PRESENTING WITH A HERNIA BULGE WHEN EXHALING. THE HERNIA PRESENTED JUST ABOVE ORIGINAL OSTOMY SITE LATERAL TO THE PATIENT UMBILICUS ON THE RIGHT ALTHOUGH CLINICIAN BELIEVED IT TO BE JUST LATERAL TO THE DEVICE PLACEMENT, WHICH WAS CONFIRMED ON CT. THE HERNIA WAS IDENTIFIED AS BULGING AT THE SITE OF DEVICE PLACEMENT. THE SURGEON REDUCED THE HERNIA AND PLACED A DIFFERENT REINFORCEMENT MATERIAL. DURING THE REPAIR SURGERY DENSE ADHESIONS WERE NOTED TO BE ATTACHED TO BOWEL REQUIRING SHARP DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796394 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY LTD. F10246-2020P ERT-21K02 09421904065130

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H