BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR KIT

    MDR report key: 3072475 · Received April 23, 2013

    Report

    Report Number
    2125050-2013-00040
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THIS REPORT. (B)(4): DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PATIENT IDENTIFIER SUBMITTED IN THE ORIGINAL REPORT WAS INCORRECT. THIS FOLLOW-UP REPORT PROVIDES THE CORRECT PATIENT IDENTIFIER. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIIFED, PATIENT WAS IMPLANTED WITH A COLOPLAST AND COMPETITOR PRODCUT ON OR ABOUT (B)(6) 2008. THE PATIENT REPORTED SHE SUFFERED SERIOUS BODILY INJURIES, INCLUDING EXTREME PAIN, BLADDER SPASAMS, CONTINUED URINARY INCONTINENCE, EROSION OF HER INTERNAL BODILY TISSUES, AND OHTER INJURIES.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIIFED, PATIENT WAS IMPLANTED WITH A COLOPLAST AND COMPETITOR PRODCUT ON OR ABOUT (B)(6) 2008. THE PATIENT REPORTED SHE SUFFERED SERIOUS BODILY INJURIES, INCLUDING EXTREME PAIN, BLADDER SPASAMS, CONTINUED URINARY INCONTINENCE, EROSION OF HER INTERNAL BODILY TISSUES, AND OHTER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174349 ARIS TRANS-OBTURATOR KIT PUBORUETHRAL SUPPORT TAPE FTL COLOPLAST A/S 5195501000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other