BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN URETEX MESH PRODUCT

    MDR report key: 3384194 · Received September 24, 2013

    Report

    Report Number
    9615742-2013-01532
    Event Type
    Injury
    Date Received
    September 24, 2013
    Date of Event
    December 11, 2009
    Report Date
    January 19, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER).

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4), (IMPORTER). (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481547 UNKNOWN URETEX MESH PRODUCT URETEX MESH OTP SOFRADIM PRODUCTION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other 2X POLYFORM SYNTHETIC MESH: REF# (B)(4)| ALIGN TO URETHRAL SUPPORT SYSTEM: HOOK | LOT#C000838| REF# (B)(4), LOT#HUTH2001| LOT#C000838| REF# (B)(4), LOT#HUTH2001| ALIGN TO URETHRAL SUPPORT SYSTEM: HOOK