BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARIS TRANS-OBTURATOR

    MDR report key: 5909521 · Received August 27, 2016

    Report

    Report Number
    2125050-2016-00187
    Event Type
    Injury
    Date Received
    August 27, 2016
    Date of Event
    November 4, 2009
    Report Date
    August 27, 2016
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    PMA / PMN Number
    K050148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. EXEMPTION NUMBER - E2014015. PRODUCT CODE - OTN. TOTAL NUMBER OF EVENTS SUMMARIZED = 400. 324 --ARIS. 11 - OMNISURE. 58 - SUPRIS. 7 - MINITAPE - ATTACHMENT: [OTN-ASR_JUNE-JULY.2016..ZIP].

    Description of Event or Problem · 0

    AS REPORTED TO COLOPLAST THOUGH NO VERIFIED, PATIENT'S LEGAL REPRESENTATIVE STATED MESH EROSION AND VAGINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561277 ARIS TRANS-OBTURATOR SURGICAL MESH OTN COLOPLAST A/S 5195501000

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other