BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 1910212 · Received November 22, 2010

    Report

    Report Number
    2210968-2010-01558
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    May 28, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DYSPAREUNIA. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE ON (B)(6)2008. ON (B)(6) 2010, THE PT REPORTED DYSPAREUNIA UPON PENETRATION. INTERVENTION IS RECORDED AS VAGINAL ESTROGEN/ VAGIFEM. THE PT HAD PRE-SURGERY / EXISTING DYSPAREUNIA. THE SURGEON REPORTS THE INTENSITY AS MILD. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3117632

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention