BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOFRADIM PRODUCT

    MDR report key: 2963139 · Received January 31, 2013

    Report

    Report Number
    9615742-2013-00039
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    April 16, 2008
    Report Date
    January 3, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43010 UNKNOWN SOFRADIM PRODUCT NONE FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R TRANS VAGINAL TAPE