BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3242650 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14131
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    September 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, BLEEDING, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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

    (B)(4). 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: 11/3/2015. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM, PLACEMENT OF JJ STENT AND DA VINCI ASSISTED LEFT URETERAL PELVIC JUNCTION OBSTRUCTION REPAIR WITH INTRAOPERATIVE NEPHROSCOPY AND REMOVAL OF TWO LOWER POLE RENAL CALCULI WITH PLACEMENT OF DRAIN ON (B)(6) 2014 DUE TO LEFT URETERAL PELVIC JUNCTION OBSTRUCTION WITH TWO LEFT LOWER POLE RENAL CALCULI. IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY AND STENT REMOVAL ON (B)(6) 2014 DUE TO INDWELLING LEFT URETERAL STENT S/P LEFT UPJ REPAIR (B)(6) 2014. IT WAS REPORTED THAT PATIENT UNDERWENT LASER LITHOTRIPSY, LEFT RETROGRADE PYELOGRAM, URETEROSCOPY, CYSTOSCOPY, STONE BASKET EXTRACTION AND PLACEMENT OF JJ STENT ON (B)(6) 2015 DUE TO LEFT RENAL CALCULUS. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: (B)(4) 2018. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(4) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 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
    343238 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3128454

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention