BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT ABREVO CONTINENCE SYSTEM

    MDR report key: 3790421 · Received May 5, 2014

    Report

    Report Number
    2210968-2014-05713
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE PHYSICIAN STRUGGLED TO GET THE TROCARS TO TURN OUT FROM THE PATIENT ONCE PUT THROUGH THE FORAMEN. IN THE END, THE MESH GOT TWISTED AND AS A RESULT WAS NOT PLACED PROPERLY. THE SLING WAS REMOVED FROM THE PATIENT. THE SITE WAS RE-EXAMINED AND A LITTLE MORE DISSECTION HAD TO BE DONE TO ENSURE THAT THERE WAS MORE SPACE FOR ANOTHER SLING TO BE INSERTED WITHOUT TWISTING. ANOTHER LIKE DEVICE WAS PLACED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269120 GYNECARE TVT ABREVO CONTINENCE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3754270

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention