BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDPOR COATED TEAR DRAIN - 3.5

    MDR report key: 3143399 · Received June 3, 2013

    Report

    Report Number
    0008010177-2013-00109
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    OKS
    PMA / PMN Number
    K012108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT COULD NOT BE DECONTAMINATED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PER SALES REP, THE COATED TEAR DRAIN CAME APART DURING IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244628 MEDPOR COATED TEAR DRAIN - 3.5 DRAIN OKS STRYKER ORTHOBIOLOGICS-MALVERN F000541

    Patients

    Seq Age Sex Outcome Treatment
    1