BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2801572 · Received October 23, 2012

    Report

    Report Number
    2210968-2012-06793
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K013718
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT POP AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF A CYSTOURETHROSCOPY, EXTRAPERITONEAL VAGINAL VAULT SUSPENSION, AND A BARD URETEX SUBURETHRAL SLING PERFORMED DURING MESH IMPLANTATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED DUE TO URINARY RETENTION, FAILED FIRST STAGE INTERSTIM. IT WAS REPORTED THAT PATIENT UNDERWENT A CYSTOSCOPY ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CYSTOURETHROSCOPY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTENSIVE EXCISION OF ANTERIOR VAGINAL MESH AND CYSTOURETHROSCOPY ON (B)(6) 2013, DUE TO FOREIGN BODY AND PELVIC PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND A FIRST STAGE INTERSTIM WAS IMPLANTED WITH DIVISION OF THE UPPER VAGINAL ADHESIONS, BILATERAL PUDENDAL NERVE BLOCK, AND BILATERAL LEVATOR MUSCLE COMPLEX BOTOX INJECTIONS ON (B)(6) 2013, DUE TO CHRONIC URINARY RETENTION, UPPER VAGINAL ADHESIONS, AND PELVIC FLOOR LEVATOR MUSCLE SPASMS. IT WAS REPORTED THAT PATIENT UNDERWENT A REMOVAL OF FIRST STAGE INTERSTIM FOLLOWED BY TRANSVAGINAL DIVISION OF SLING WITH INTRAOPERATIVE CYSTOSCOPY ON (B)(6) 2014 DUE TO URINARY RETENTION AND FAILED FIRST STAGE INTERSTIM. IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIGH UTEROSACRAL VAULT SUSPENSION ANTERIOR REPAIR, INTRAOPERATIVE CYSTOSCOPY, LEVATORPLASTY ON (B)(6) 2014 DUE TO SYMPTOMATIC PROLAPSE AND URINARY RETENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH AND A BARD URETEX WERE 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
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON INC NA 3135681

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention BARD URETEX