BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3252839 · Received July 29, 2013

    Report

    Report Number
    2210968-2013-14946
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    June 6, 2017
    Manufacturer
    ETHICON SARL
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT FOLLOWING INSERTION PATIENT EXPERIENCED STRESS INCONTINENCE, URGE INCONTINENCE, DYSPAREUNIA AND URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNDISCLOSED DATE AT AN UNDISCLOSED LOCATION AND MESH WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352205 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON SARL UNK 3674602

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention