BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3043518 · Received April 9, 2013

    Report

    Report Number
    2210968-2013-03558
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    November 6, 2012
    Report Date
    March 21, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE FOR URINARY INCONTINENCE ON (B)(6) 2011. THE PATIENT DEVELOPED A RETROPUBIC ABSCESS WHERE THERE THE MESH WAS LOCATED. THE ABSCESS WAS DRAINED AND THE SLING WAS REMOVED ON (B)(6) 2012. NO ADDITIONAL TREATMENT IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144811 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention