BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 1900188 · Received November 10, 2010

    Report

    Report Number
    2210968-2010-01498
    Event Type
    Injury
    Date Received
    November 10, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DYSPAREUNIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING (B)(6) 2005 THE PATIENT UNDERWENT TRANSVAGINAL TAPE, BLADDER SLING, URETHRAL SUSPENSION, AND CYSTOCELE REPAIR PROCEDURES. THE PATIENT EXPERIENCED EROSION, SHRINKAGE, AND EXTRUSION OF MESH FROM ONE OR MORE OF THE MESH DEVICES, CAUSING URINARY RETENTION, PERSISTENT PAIN, DYSPAREUNIA AND NUMEROUS SURGICAL PROCEDURES TO REMOVE THE MESH DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MESH PRODUCT (EWHU) MESH, SURGICAL FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention