BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3230993 · Received July 17, 2013

    Report

    Report Number
    2210968-2013-13481
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DYSPAREUNIA; URINARY PROBLEMS. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 FOR SUI AND PROLAPSE AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT HAD THE BIOARC SP SLING; (B)(4) AND ANS - INTEXEN MATRIX (B)(4) IMPLANTED. NO CLARIFYING INFORMATION HAS BEEN PROVIDED. IT IS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, INFECTION, WORSENED INCONTINENCE, DYSPAREUNIA AND URINARY PROBLEMS, 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
    331782 GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention