BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT-AA ABDOMINAL

    MDR report key: 3250107 · Received July 26, 2013

    Report

    Report Number
    2210968-2013-14710
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    August 5, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT HYSTERECTOMY DUE TO POP AND SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, URINARY/BOWEL PROBLEMS, BLEEDING AND VAGINAL SCARRING. (B)(4).

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW HAS BEEN INSERTED INTO THE FILE. THIS REVIEW INDICATES THAT THERE WAS NO QUALITY CONCERNS ASSOCIATED WITH THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WERE IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, DISCOMFORT, PRESSURE, DIFFICULTY VOIDING URINE, CONTINUED INCONTINENCE, DISCHARGE, SCARRING, INFECTION, ODOR, BLEEDING, 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
    350423 GYNECARE TVT-AA ABDOMINAL MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3389747

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention