BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3242779 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14165
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    May 2, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE CONCURRENTLY WITH HYSTERECTOMY/BSO; CYSTOSCOPY ON (B)(6) 2005 DUE TO SUI, MENOMETRORRHAGIA, FIBROID AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY PROBLEMS, DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT TRACHELECTOMY; ANTERIOR & POSTERIOR REPAIR; SACROSPINOUS LIGAMENT SUSPENSION ON (B)(6) 2005. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF VAGINAL SLING ON (B)(6) 2009.

    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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BLADDER OUTLET OBSTRUCTION, INFECTION AND VAGINAL SCARRING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344284 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 1224293

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention