BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN URETHRAL SLING

    MDR report key: 5059302 · Received September 5, 2015

    Report

    Report Number
    1835959-2015-00192
    Event Type
    Injury
    Date Received
    September 5, 2015
    Report Date
    September 10, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K992159
    Removal / Correction Number
    1835959-2015-00192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED . CONCOMITANT PRODUCT(S): AMS MINIARC SLING AND A MONARC SUBFACIAL HAMMOCK: (B)(6) 2003, BARD ACELLULAR COLLAGEN MATRIX: (B)(6) 2011. MFG DATE: PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH AMS MINIARC SLING AND A MONARC SUBFACIAL HAMMOCK ON (B)(6) 2003, A COOK STRATASIS URETHRAL SLING ON (B)(6) 2005, AND A BARD ACELLULAR COLLAGEN MATRIX ON (B)(6) 2011 TO TREAT HER STRESS URINARY INCONTINENCE AND/OR PELVIC ORGAN PROLAPSE. THE SURGERIES TOOK PLACE AT (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH AMS MINIARC SLING AND A MONARC SUBFACIAL HAMMOCK ON (B)(6) 2003, A COOK STRATASIS URETHRAL SLING ON (B)(6) 2005, AND A BARD ACELLULAR COLLAGEN MATRIX ON (B)(6) 2011 TO TREAT HER STRESS URINARY INCONTINENCE AND/OR PELVIC ORGAN PROLAPSE. THE SURGERIES TOOK PLACE AT (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590625 BIODESIGN URETHRAL SLING URETHRAL SLING FTM COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1