BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3881676 · Received June 18, 2014

    Report

    Report Number
    2210968-2014-07826
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE ON AN UNKNOWN DATE. AT A LATER DATE THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE. IT WAS OPINED BY THE PHYSICIAN THAT THE PATIENT WILL LIKELY LOSE ANY COITAL FUNCTION AS HER VAGINAL LENGTH IS NOW 3CM, AND THERE IS MESH EXTRUDING. THE PATIENT ALSO HAD A LARGE STONE IN THE BLADDER FROM A BLADDER PERFORATION WITH THE ANTERIOR ARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358097 GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention