BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3232525 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13558
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 25, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    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): 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). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED AS PER PATIENT PROFILE FORM DUE TO STRESS URINARY INCONTINENCE. IT WAS ALSO REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION , URINARY PROBLEMS, ORGAN PERFORATION, BLEEDING, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED MESH EROSION AND UNDERWENT MESH REVISION ON (B)(6) 2008. ADDITIONALLY, THE PATIENT UNDERWENT PARTIAL REMOVAL OF MESH IN 2007 DUE TO MESH EXTRUSION AND EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (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. 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
    333485 GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 2893626

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention MONARC HAMMOCK (AMS)| MONARC HAMMOCK (AMS)