BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3063015 · Received April 17, 2013

    Report

    Report Number
    2210968-2013-04009
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT SYMPTOMATIC PELVIC RELAXATION, THIRD DEGREE CYSTOURETHROCELE, UTEROVAGINAL PROLAPSE AND RECTOCELE. IT WAS REPORTED THAT THE FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY PROBLEMS, RECURRENCE AND EXTRUSION. IN ADDITION TO MESH REVISION ON (B)(6) 2011 THE PATIENT UNDERWENT ROBOTIC SUPRACERVICAL HYSTERECTOMY AND IMPLANTED MINIARC PRECISE AT THE SAME TIME DUE TO STRESS URINARY INCONTINENCE, THIRD DEGREE RECURRENT PROLAPSE, HYPERMOBILE BLADDER NECK AND MESH EROSION. (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). IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2011 AND PARTIAL HYSTERECTOMY IN 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS USED. THE PATIENT 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164058 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3135684

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention