BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3232600 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13559
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND A MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR AND POSTERIOR REPAIR, AND PERINEOPLASTY DUE TO UTERINE VAGINAL PROLAPSE. IT WAS REPORTED THAT PATIENT UNDERWENT VAGINAL MESH REVISION/REMOVAL, SLING REVISION/REMOVAL AND CYSTOSCOPY ON (B)(6) 2014 DUE TO CONSTIPATION AND VAGINAL FOREIGN BODY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2011 AND MESH WERE IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333757 GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention