BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT ABBREVO CONTINENCE SYSTEM

    MDR report key: 3242824 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14169
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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 INCONTINENCE ON (B)(6) 2013. CONCOMITANTLY, THE PATIENT UNDERWENT A LAPAROSCOPIC VAGINAL ASSISTED HYSTERECTOMY WITH AN ANTERIOR AND POSTERIOR REPAIR. ON (B)(6) 2013 THE PATIENT COULD ONLY VOID SMALL AMOUNTS AND THE SLING WAS ADJUSTED AND LOOSENED. ON (B)(6) 2013, THE PATIENT RETURNED AND 1000CC OF RETAINED URINE WAS DRAINED. THE CATHETER WAS LEFT IN PLACE UNTIL (B)(6) 2013. CURRENTLY, THE PATIENT IS STILL UNABLE TO VOID TO COMPLETION. THE SURGEON IS CONSIDERING TAKING PATIENT BACK TO OPERATING ROOM TO RELEASE THE SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343276 GYNECARE TVT ABBREVO CONTINENCE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention