BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVITEX REINFORCED BIOSCAFFOLD

    MDR report key: 10192612 · Received June 24, 2020

    Report

    Report Number
    3007321028-2020-00009
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    December 24, 2019
    Report Date
    June 25, 2020
    Manufacturer
    AROA BIOSURGERY LTD.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DESCRIPTION WAS UPDATED TO CORRECT THE INITIAL DATE OF SURGERY FROM (B)(6) 2019. AND THE DEVICE MANUFACTURE DATE WAS REMOVED, AS THIS IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OVITEX MESH PLACED ON (B)(6) 2019 TO REPAIR AN INGUINAL HERNIA WAS REMOVED ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    UNABLE TO REVIEW MANUFACTURING RECORDS DUE TO LACK OF INFORMATION ABOUT THE CATALOGUE NUMBER/LOT OF THE EXPLANTED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OVITEX MESH PLACED ON (B)(6) 2019 TO REPAIR AN INGUINAL HERNIA WAS REMOVED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656211 OVITEX REINFORCED BIOSCAFFOLD SURGICAL MESH FTM AROA BIOSURGERY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization