BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2834047 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07318
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO PELVIC ORGAN PROLAPSE. THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2013 DUE TO EROSION. IT WAS REPORTED THAT PATIENT UNDERWENT CREATION OF RECTUS FASCIA SUBURETHRAL SLING ON (B)(6) 2013. (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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL SUPRACERVICAL HYSTERECTOMY, ABDOMINAL SACROCOLPOPEXY, REMOVAL OF PANNUS, ABDOMINAL ENTEROCELE REPAIR, CYSTOCELE REPAIR, ANTERIOR COLPORRHAPHY, RECTOCELE REPAIR, POSTERIOR COLPORRHAPHY, AND COLPOPERINEORRHAPHY ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 1395287

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention