BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2032724 · Received March 17, 2011

    Report

    Report Number
    2210968-2011-00298
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - URINARY TRACT INFECTION. 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 FOR THE SAME PT. SEE ALSO MEDWATCH 2210968-2011-00300.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE AND A SLING PROCEDURE ALONG WITH A DILATION AND CURETTAGE AND A HYSTEROSCOPY PROCEDURE ON (B)(6) 2011. THE PT WAS GIVEN A CATHETER FOR ONE DAY. ON (B)(6) 2011, THE PT HAD A URINARY TRACT INFECTION AND ORAL MACROBID WAS GIVEN. THE URINE CULTURE GREW (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3465176

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention THERMACHOICE