BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIMEND ADV. 20 X 30

    MDR report key: 3030487 · Received March 27, 2013

    Report

    Report Number
    2523190-2013-00015
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    INTEGRA YORK PA, INC.
    Product Code
    LYC
    PMA / PMN Number
    K992216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS MEMBRANE DISSOLVED AND WAS ABSENT IN 2 WEEKS. ON (B)(6) 2013 DOCTOR STATES SINCE MEMBRANE DISSOLVED THE BONE GRAFT IS IN JEOPARDY OF BEING LOST. HE SAID HE BELIEVES THE MEMBRANE SHOULD LAST 8-10 WEEKS. DOCTOR SAYS HE'S NOT SURE IF HE DID SOMETHING WRONG. PRODUCT SPECIALIST TO SPEAK WITH HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126514 HELIMEND ADV. 20 X 30 M54 - ORAL SURGERY LYC INTEGRA YORK PA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1