BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED BIOSCAFFOLD

    MDR report key: 10189578 · Received June 24, 2020

    Report

    Report Number
    3010513348-2020-00004
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    June 4, 2020
    Report Date
    June 24, 2020
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065031
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A POTENTIAL "REACTION" TO AN OVITEX P MESH IMPLANTED ON (B)(6) 2019. IT WAS REMOVED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653759 OVITEX REINFORCED BIOSCAFFOLD SURGICAL MESH FTM AROA BIOSURGERY F10244-1020P ERT-8F03 09421904065031

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization