BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3121492 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05703
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. 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 ON (B)(6) 2008 CONCURRENTLY WITH CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE, VAGINAL PROLAPSE AND PELVIC FLOOR REPAIR WITH LARGE CYSTOCELE AND RECTOCELE. ON (B)(6) 2009, THE PATIENT HAD INTEPRO LPP Y-SLING BY AMS IMPLANTED CONCURRENTLY WITH REPAIR OF ENTEROCELE, ROBOTIC ASSISTED SACROCOLPOPEXY AND LYSIS OF ADHESIONS DUE TO PELVIC FLOOR RELAXATION WITH A LARGE ENTEROCELE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT PATIENT UNDERWENT EXCISION OF ERODED VAGINAL MESH AND REPEAT ENTEROCELE REPAIR WITH CLOSURE OF APEX ON (B)(6) 2013, DUE TO VAGINAL PAIN, VAGINAL MESH EROSION, AND RECURRENT ENTEROCELE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, LYSIS OF BOWEL ADHESIONS, RETROPERITONEAL EXPLORATION FOR EXCISION OF PELVIC MESH AND CLOSURE OF VAGINAL APEX, CYSTOSCOPY ON (B)(6) 2015 DUE TO PELVIC PAIN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF 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
    224528 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3074115

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention