BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXAIR ANTERIOR KIT

    MDR report key: 6189685 · Received December 20, 2016

    Report

    Report Number
    2125050-2016-00388
    Event Type
    Injury
    Date Received
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    OTP
    PMA / PMN Number
    K112386
    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. TOTAL NUMBER OF EVENTS SUMMARIZED - 47. EXAIR ANTERIOR - 33. EXAIR POSTERIOR - 14 - ATTACHMENT: [OTP OCT NOV 2016.ZIP].

    Description of Event or Problem · 0

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT'S LEGAL REPRESENTATIVE STATED MESH EROSION, FOUL SMELLING DISCHARGE, AND RECURRENT PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841930 EXAIR ANTERIOR KIT SURGICAL MESH OTP COLOPLAST MANUFACTURING US, LLC 5010001022

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other