BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2932788 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00556
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED DUE TO STRESS INCONTINENCE, VAGINAL VAULT PROLAPSE, ENTEROCELE, LATERAL CYSTOCELE, WEAKENING OF PUBOCERVICAL CONNECTIVE TISSUE, RECTOCELE, AND ATROPHY. THE PATIENT EXPERIENCED RECURRENT ANTERIOR AND APICAL PROLAPSE. ON (B)(6) 2009, SACROSCOSPINOUS VAULT SUSPENSION UTILIZING A FOUR WALL MICHIGAN TECHNIQUE, THIS WAS PERFORMED APICALLY BY ATTACHING SUTURES TO THE ANTERIOR MESH, PERINEOPLASTY AND CYSTOURETHROSCOPY WERE PERFORMED. THE PATIENT UNDERWENT A VAGINAL FOREIGN BODY EXCISION ON (B)(6) 2011. (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

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-00557. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 07/28/2016.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED DYSPAREUNIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2011. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-00557. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT CODES: (B)(4) - VAGINAL ITCHING, (B)(4) - URINARY TRACT INFECTION, (B)(4) - URINARY FREQUENCY,(B)(4) - URINARY URGENCY ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL ITCHING, URINARY TRACT INFECTION, URINARY FREQUENCY AND URINARY URGENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39726 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3043596

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention