BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 4951167 · Received July 29, 2015

    Report

    Report Number
    2210968-2015-10050
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    September 12, 2017
    Manufacturer
    ETHICON SARL
    Product Code
    OTP
    PMA / PMN Number
    K013718
    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). 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 SURGICAL PROCEDURE ON (B)(4) 2007 AND PROLIFT WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND AN UNKNOWN MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED COMPLICATIONS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492655 GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON SARL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention