BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR KIT

    MDR report key: 3212977 · Received July 9, 2013

    Report

    Report Number
    2125050-2013-00064
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    July 8, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. (B)(4): DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT IMPLANTED WITH ARIS SLING FOR TREATMENT OF INCONTINENCE. IT WAS ALSO REPORTED THAT THE MESH HAD COME APART AND EMBEDDED ITSELF IN THE WALL OF THE VAGINA. A SECOND PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314069 ARIS TRANS-OBTURATOR KIT PUBORUETHRAL SUPPORT TAPE FTL COLOPLAST A/S 5195501000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other