BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    MDR report key: 3191307 · Received June 26, 2013

    Report

    Report Number
    2210968-2013-11276
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    February 21, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT CYSTOSCOPY, SACROSPINOUS LIGAMENT FIXATION, AND ANTERIOR/POSTERIOR COLPORRHAPHY DUE TO SUI, POP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2007; MESH WERE IMPLANTED, AND A MESH WITH CYSTOSCOPY ON (B)(6) 2007; MESH WAS IMPLANTED INTO THE PATIENT, FOR RECURRENT SUI. IT IS REPORTED THAT THE (B)(6) 2007 PROCEDURE WAS AN A/P COLPORRHAPHY WITH MESH, SACROSPINOUS LIGAMENT FIXATION, MESH AND CYSTOSCOPY; FOR A RECTOCELE, CYSTOCELE, VAGINAL WALL PROLAPSE AND SUI. IT IS ALSO REPORTED THAT 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
    289807 GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK 2980421

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention