BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2143352 · Received June 29, 2011

    Report

    Report Number
    2210968-2011-00840
    Event Type
    Injury
    Date Received
    June 29, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY AND SLING PROCEDURE ON (B)(6) 2010. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED AN INFECTION IN THE AREA SURROUNDING THE MESH WHICH RESULTED IN THE DEVELOPMENT OF POCKETS OF INFECTION WHICH HAD BEEN DEVELOPING PUS REGULARLY. THE POCKETS WERE DRAINED ON (B)(6) 2010 AND THE WOUND WAS LEFT OPEN. PUS STILL DEVELOPS AT THE WOUND FROM TIME TO TIME. THE PATIENT WAS PRESCRIBED INJECTABLE STREPTOMYCIN 0.75 GM ONCE DAILY, L.CIN 500 1 TAB DAILY, R. CINEX 600 1 TAB DAILY , COMBUTOL 1.2GM 1 TAB DAILY, PZA 750 2 TABS DAILY , BENADON 40 1/2 TAB DAILY, CITRAN 750 1 TAB DAILY, AND ZENIT 1 TAB DAILY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention