BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3963525 · Received July 29, 2014

    Report

    Report Number
    2210968-2014-10234
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    November 18, 2010
    Report Date
    July 10, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE AND CYTOSCOPY FOR STRESS INCONTINENCE ON (B)(6) 2010. POST OPERATIVELY, THE GYNECOLOGIST REPORTED THAT THE PATIENT HEMORRHAGED AND IT INVOLVED THE MESH WHICH THEREFORE DID NOT LIE PROPERLY AND ERODED. THE MESH ERODED INTO HER URETHRA. UP UNTIL (B)(6) 2012, THE PATIENT REQUIRED SEVEN PROCEDURES TO EXCISE THE ERODED MESH. THE PATIENT HAS ONGOING PAIN, WALKS WITH A STICK AT TIMES, AND NEEDS ONGOING PSYCHOTHERAPY AND PHYSIOTHERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442007 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3422079

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention