BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3072759 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04301
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2006 DUE TO PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. THE PATIENT EXPERIENCED PAIN, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, RECURRENCE, BLEEDING, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2007 FOR MESH EXPOSURE AND MESH EXPLANT SURGERY ON (B)(6) 2011 FOR PELVIC PAIN AND DYSPAREUNIA. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTENSIVE TRANSVAGINAL URETHROLYSIS, EXPLORATION OF ADDUCTOR AND OBTURATOR FOSSA FOR MESH REMOVAL, TRANSOBTURATOR SLING MESH REMOVAL, TRANSVAGINAL HYSTERECTOMY, VAGINAL VAULT SUSPENSION USING A MODIFIED SACROSPINOUS LIGAMENT FIXATION, RECTOCELE REPAIR ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT UNDERWENT AUTOLOGOUS PARTIAL SLING WITH A DONOR SITE FROM THE LEFT THIGH, CENTRAL DEFECT REPAIR USING A PDS SUTURES, REPAIR OF VAGINAL STENOSIS WITH ADVANCEMENT OF POSTERIOR VAGINAL FLAP, TRANSVAGINAL UREHTROLYSIS, CYSTOSCOPY ON (B)(6) 2015. (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. 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 FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL PROLAPSE, RECURRENT URINARY TRACT INFECTION, AND URGE INCONTINENCE. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 7/22/2016. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED FREQUENCY AND INCOMPLETE BLADDER EMPTYING. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT SACROSPINOUS LIGAMENT FIXATION, REPAIR OF RECTAL LACERATION, AND ANTERIOR REPAIR WITH MESH PLACEMENT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URGENCY, NOCTURIA, VAGINAL BULGE AND SLOW URINE STREAM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2006 AND MESH AND AMS MONARC SUBFASCIAL HAMMOCK WERE IMPLANTED. IT WAS REPORTED THAT SHE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT SACROSPINOUS LIGAMENT FIXATION, REPAIR OF RECTAL LACERATION, AND ANTERIOR REPAIR WITH MESH PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174753 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 1368188

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention AMS MONARC SUBFASCIAL HAMMOCK