BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR

    MDR report key: 3842847 · Received August 21, 2013

    Report

    Report Number
    2125050-2013-00163
    Event Type
    Injury
    Date Received
    August 21, 2013
    Date of Event
    December 19, 2007
    Report Date
    August 21, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFO CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PT EXPERIENCED RECURRENT STRESS URINARY INCONTINENCE AND URGE INCONTINENCE, RECURRENT CYSTOCELE, EROSION, TAPE MIGRATION, CHRONIC PAIN, SCAR TISSUE AND TROUBLE WITH BOWEL MOVEMENTS. AN EXCISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407069 ARIS TRANS-OBTURATOR POLYMERIC SURGICAL MESH FTL COLOPLAST A/S 5195501000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other