BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3063526 · Received April 17, 2013

    Report

    Report Number
    2210968-2013-04032
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2004 IN ORDER TO TREAT STRESS INCONTINENCE, POST OPERATIVE VAGINAL PROLAPSE, AND URETHRAL HYPERMOBILITY CONCURRENTLY WITH CYSTOCELE/RECTOCELE REPAIR AND URINE INCONTINENCE REPAIR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED CONCURRENTLY WITH IN-FAST ULTRA (AMERICAN MEDICAL SYSTEMS) DUE TO PELVIC ORGAN PROLAPSE. THE PATIENT EXPERIENCED EXTRUSION, URINARY PROBLEMS AND RECURRENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXPOSED MESH DUE TO MESH EXPOSURE AND RECURRENCE OF STRESS URINARY INCONTINENCE ON (B)(6) 2012. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS IMPLANTED. 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
    164761 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA SPE178

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention