BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 15222876 · Received August 14, 2022

    Report

    Report Number
    3007321028-2022-00027
    Event Type
    Injury
    Date Received
    August 14, 2022
    Report Date
    August 15, 2022
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    PMA / PMN Number
    K130547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSUFFICIENT DEVICE INFORMATION RECEIVED TO CONDUCT INVESTIGATION OF MANUFACTURING RECORDS. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEVELOPED ABDOMINAL REDNESS AFTER HERNIA REPAIR WITH OVITEX 2S. THE PATIENT RETURNED TO THE OR FOR INCISION AND DRAINAGE WHERE PIECES OF THE REPAIR MATERIAL WERE REMOVED WITH APPROXIMATELY TWO LITERS OF FLUID. IT WAS REPORTED THAT THE HERNIA REPAIR REMAINED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790925 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H