BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2980982 · Received February 27, 2013

    Report

    Report Number
    2210968-2013-01800
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 7, 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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2008 AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS , BLEEDING, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING. THE PATIENT EXPERIENCED UTERINE DESCENSUS WITH PROLAPSE AND UNDERWENT MESH REVISION AND REMOVAL OF POSTERIOR REPAIR ON (B)(6) 2012; DURING THIS PROCEDURE, AMS INTEPRO LLP Y- SLING AND AMS MINIARC PRECISE WERE IMPLANTED CONCURRENTLY WITH A HYSTERECTOMY DUE TO RECURRENT STRESS URINARY INCONTINENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT PATIENT UNDERWENT REVISION, EXPOSURE AND EXCISION OF VAGINAL MESH ON (B)(6) 2009 DUE TO DYSPAREUNIA FOLLOWING RECTOCELE REPAIR. IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA .THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-01803. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL BLEEDING, POSTOPERATIVE BLEEDING, STRESS URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE, AND PERINEAL RELAXATION. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT REPAIR OF VAGINAL TEAR ON (B)(6) 2012 BY DR. (B)(6) AND ON (B)(6) 2012 PATIENT HAD SUPRACERVICAL LAPAROSCOPIC ROBOTIC HYSTERECTOMY WITH BSO, VAGINAL SACROCOLPOPEXY, PERINEORRHAPHY, MID URETHRAL SLING AND CYSTOSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL BLEEDING, POSTOPERATIVE BLEEDING, STRESS URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE, AND PERINEAL RELAXATION. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT REPAIR OF VAGINAL TEAR ON (B)(6) 2012 BY DR. (B)(6) AND ON (B)(6) 2012 PATIENT HAD SUPRACERVICAL LAPAROSCOPIC ROBOTIC HYSTERECTOMY WITH BSO, VAGINAL SACROCOLPOPEXY, PERINEORRHAPHY, MID URETHRAL SLING AND CYSTOSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE.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
    84354 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 3109572

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention