BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 15489429 · Received September 26, 2022

    Report

    Report Number
    3007321028-2022-00036
    Event Type
    Injury
    Date Received
    September 26, 2022
    Report Date
    September 27, 2022
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    UDI-DI
    09421904065031
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE RELEVANT BATCH RECORD WAS CONDUCTED WHICH SHOWED THE DEVICE LOT MET ALL RELEASE SPECIFICATIONS AND NO RELEVANT ANOMALIES OR NON-CONFORMANCES WERE NOTED. NO OTHER SIMILAR REPORTS HAVE BEEN NOTED ASSOCIATED WITH THIS LOT ASIDE FROM THESE FOUR RECURRENCES NOTED. A REVIEW OF SALES RECORDS NOTED THAT THIS DEVICE LOT HAS BEEN UTILIZED AT THIS HOSPITAL 34 TIMES WITH NO OTHER ISSUES REPORTED. FURTHER, BALL BURST TESTING WAS COMPLETED ON AVAILABLE SAMPLES FROM THE SAME LOT. ALL SAMPLES TESTED MET THE PRE-DEFINED STRENGTH SPECIFICATION. IT WAS NOTED BY THE SURGEON THAT THE HERNIA RECURRENCE REPAIR WAS CONDUCTED IN A DIFFERENT MANNER AS THE ORIGINAL REPAIR, THUS A SURGICAL ASSESSMENT OF THE ORIGINAL REPAIR AND THE SURGICAL MESH COULD NOT BE CONDUCTED.

    Description of Event or Problem · 0

    A SURGEON REPORTED FOUR SEPARATE INDIRECT INGUINAL HERNIA RECURRENCES AFTER INGUINAL HERNIA REPAIR WITH OVITEX CORE. ALL RECURRENCES WERE ADDRESSED VIA A SECOND REPAIR OPERATION. THIS IS ONE OF THESE FOUR REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045244 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY LTD. F10244-1020P ERT-21K10 09421904065031

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention