BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT-AA ABDOMINAL

    MDR report key: 3202484 · Received July 2, 2013

    Report

    Report Number
    2210968-2013-11907
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    October 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE CONCURRENTLY WITH CYSTOSCOPY AND ANTERIOR COLPORRHAPHY ON (B)(6) 2009 DUE TO PELVIC ORGAN PROLAPSED AND STRESS URINARY INCONTINENCE AND A MESH WERE IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/29/2017. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT DIED ON AN UNDISCLOSED DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WERE IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302184 GYNECARE TVT-AA ABDOMINAL MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3238449

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention