BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR

    MDR report key: 6952972 · Received October 16, 2017

    Report

    Report Number
    2125050-2017-00506
    Event Type
    Injury
    Date Received
    October 16, 2017
    Report Date
    October 16, 2017
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. THIS MDR IS CREATED TO DOCUMENT THE ASR / PRODUCT CODE OTN / EXEMPTION # E2014015. TOTAL NUMBER OF EVENTS SUMMARIZED: 33. ARIS - 32. SUPRIS - 1 - ATTACHMENT: [OTN ASR AUG SEPT 2017 Q4.ZIP].

    Description of Event or Problem · 0

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT'S LEGAL REPRESENTATIVE STATED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732091 ARIS TRANS-OBTURATOR SURGICAL MESH OTN COLOPLAST A/S 5195501000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other