BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3261012 · Received August 2, 2013

    Report

    Report Number
    2210968-2013-15512
    Event Type
    Injury
    Date Received
    August 2, 2013
    Report Date
    June 28, 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).

    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT ENTEROCELE REPAIR, CYSTOSCOPY DUE TO CYSTOCELE WITH STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED ¿SEX IS PAINFUL, SUFFERED FROM ANXIETY AND DEPRESSION, PROBLEMS WITH URINATION UNTIL FURTHER SURGERY COULD BE PERFORMED, SEVERE PAIN, INFECTION, EROSION OF MESH INTO TISSUE AND ORGANS, AND LIGHT BLEEDING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL OF MESH REMOVED IN WHOLE ON (B)(6) 2006 DUE TO DIFFICULTY WITH URINATION AND HAD AN INFECTION. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL OF MESH REMOVED IN PART ON (B)(6) 2007 DUE TO SEVERE PAIN AND UNABLE TO HAVE SEX. NO ADDITIONAL INFORMATION PROVIDED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WERE IMPLANTED INTO THE PATIENT. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 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
    361840 GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention