BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED BIOSCAFFOLD

    MDR report key: 8190303 · Received December 21, 2018

    Report

    Report Number
    3007321028-2018-00002
    Event Type
    Injury
    Date Received
    December 21, 2018
    Report Date
    December 21, 2018
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    UDI-DI
    09421904065277
    PMA / PMN Number
    K153633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE SURGEON WHO PERFORMED THE BREAST RECONSTRUCTION AND NO INFORMATION WAS RECEIVED. IT IS UNKNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT OR IT WAS DUE TO OTHER FACTORS SUCH AS OTHER DEVICES USED, SURGICAL TECHNIQUE, OR OTHER CIRCUMSTANCES. THE COMPANY CONTINUES TO ATTEMPT TO RETREIEVE MORE INFORMATION. TELA BIO (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AROA BIOSURGERY (MANUFACTURER) VIA EXEMPTION NUMBER E2017045.

    Description of Event or Problem · 0

    A PATIENT REPORTED THAT SHE UNDERWENT BILATERAL BREAST RECONSTRUCTION IN WHICH OVITEX WAS UTILIZED. SHE REPORTED THAT SOMETIME AFTER THE PROCEDURE THAT SHE BELIEVED THAT THE MESH DID NOT STAY IN PLACE IN ONE BREAST AND THE IMPLANT "ALMOST LITERALLY FELL OUT". THE BREAST IMPLANT ENDED UP BEING SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030707 OVITEX REINFORCED BIOSCAFFOLD SURGICAL MESH FTM AROA BIOSURGERY ERT-8C06 09421904065277

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R