BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3040241 · Received March 18, 2013

    Report

    Report Number
    9615742-2013-00207
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    August 3, 2004
    Report Date
    February 22, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K012949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: PELVICOL ACELLULAR COLLAGEN MATRIX. CATALOG # 482812, LOT# 04B06-1. (B)(6).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00909 AND 1018233-2013-00911.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112112 URETEX SUPPORT PP KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION NA C24062SUP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R URETEX SUP URETHRAL SUPPORT SYSTEM| PELVICOL ACELLULAR COLLAGEN MATRIX| PELVICOL (BARD) 8CM X 12CM: 482812, LOT #04B06-1| PELVICOL (BARD) 8CM X 12CM: 482812, LOT #04B06-1