BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3173041 · Received June 17, 2013

    Report

    Report Number
    2210968-2013-10253
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    June 13, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    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). 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

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT LAPAROTOMY WITH BSO AND LYSIS OF ADHESIONS, ABDOMINAL SACROCOLPOPEXY WITH ALYTE MESH AND CYSTOSCOPY ON (B)(6) 2012 DUE TO RECURRENT SYMPTOMATIC PELVIC RELAXATION WITH A VAGINAL VAULT PROLAPSE AND PELVIC ADHESIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/16/2016.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY/BOWEL PROBLEMS, RECURRENCE, BLEEDING, AND NEUROMUSCULAR PROBLEMS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED INTO THE PATIENT. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE 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
    274003 GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 2922768

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention