BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2961499 · Received February 14, 2013

    Report

    Report Number
    2210968-2013-01133
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE MESH EXPOSURE FOUND DURING THE FOLLOW UP VISIT ON 08/11/2011 WAS LESS THAN 1 CM. CURRENTLY, THE PATIENT STILL HAS URGENCY AND OCCASIONAL URGE INCONTINENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2011. DURING THE FOLLOW-UP VISIT ON (B)(6) 2011, A SMALL TAPE EXPOSURE IN THE SUTURE LINE WAS NOTED. THERE WAS NO ACTION TAKEN AS THE PATIENT WAS ASYMPTOMATIC AT FIRST PRESENTATION. THE PATIENT WAS DISCHARGED BUT WAS RE-REFERRED WITH PERSISTENT URINARY SYMPTOMS ON (B)(6) 2012 BUT HAS DECLINED FURTHER FOLLOW UP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66091 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3482980

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention