BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED TISSUE MATRIX

    MDR report key: 13001805 · Received December 14, 2021

    Report

    Report Number
    3010513348-2021-00007
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 14, 2021
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065277
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A PERSISTENT SEROMA AFTER IMPLANTATION OF OVITEX R TO REINFORCE A DIEP FLAP DONOR SITE ON (B)(6) 2021. THE IMPLANTED MATERIAL WAS PARTIALLY REMOVED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902729 OVITEX REINFORCED TISSUE MATRIX SURGICAL MESH FTM AROA BIOSURGERY F10254-2020G ERT-21A02 09421904065277

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention| H