BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT +M ANTERIOR PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3230998 · Received July 17, 2013

    Report

    Report Number
    2210968-2013-13484
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    November 10, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO URINARY INCONTINENCE AND CYSTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, ORGAN PERFORATION, BLEEDING, & DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF ERODED VAGINAL MESH ON (B)(6) 2012 & (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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.

    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). CORRECTED NARRATIVE: IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010, AND A MESH WAS IMPLANTED DUE TO URINARY INCONTINENCE, AND CYSTOCELE. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, ORGAN PERFORATION, BLEEDING, DYSPAREUNIA, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. IT WAS REPORTED THAT PATIENT UNDERWENT AN EXCISION OF ERODED VAGINAL MESH ON (B)(6) 2012, (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT ANTERIOR REPAIR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL DISCHARGE AND SEVERE URINARY INCONTINENCE. IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOURETHROSCOPY AND MESH REVISION ON (B)(6) 2013 BY DR. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS 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
    330539 GYNECARE PROLIFT +M ANTERIOR PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 3436444

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention