BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXAIR ANTERIOR KIT

    MDR report key: 6354332 · Received February 23, 2017

    Report

    Report Number
    2125050-2017-00028
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    February 16, 2015
    Manufacturer
    COLOPLAST A/S
    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. OTP EXEMPTION NUMBER E2014015. TOTAL NUMBER OF EVENTS SUMMARIZED - 2. EXAIR ANTERIOR - 2 - ATTACHMENT: [OTP DEC JAN 2016-17 .ZIP].

    Description of Event or Problem · 0

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT'S LEGAL REPRESENTATIVE STATED RECURRENT PROLAPSE, INCOMPLETE EMPTYING, VAGINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136576 EXAIR ANTERIOR KIT SURGICAL MESH OTP COLOPLAST A/S 5010002400

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other