BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3233601 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13646
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    November 10, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2005 DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, BLEEDING, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA. IT WAS REPORTED THAT ON(B)(6) 2006: PATIENT UNDERWENT PARTIAL REMOVAL DUE TO EXTRUSION INTO VAGINA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 05/26/2016. ADDITIONAL INFORMATION: AGE AT TIME OF EVENT, DATE OF BIRTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WERE IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, 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
    334632 GYNECARE PROLIFT ANTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 1327888

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention