BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL BLOCK TRAY

    MDR report key: 4791331 · Received May 20, 2015

    Report

    Report Number
    1722447-2015-00003
    Event Type
    Other
    Date Received
    May 20, 2015
    Report Date
    April 30, 2015
    Manufacturer
    INTEGRA PAIN MANAGEMENT
    Product Code
    CAZ
    PMA / PMN Number
    K960248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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 INFO.

    Description of Event or Problem · 1

    CUSTOMER REPORTS: HAIR FOUND INSIDE TRAY WHEN PREPARING FOR PROCEDURE. TRAY WAS DISCARDED. TINY BLACK SPECS APPEAR TO BE MOLDED INTO THE PLASTIC TRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327552 UNIVERSAL BLOCK TRAY 44-TRAYS CAZ INTEGRA PAIN MANAGEMENT W1502179

    Patients

    Seq Age Sex Outcome Treatment
    1