BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBP PUTTY 5CC

    MDR report key: 2443540 · Received January 24, 2012

    Report

    Report Number
    2090010-2012-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 23, 2012
    Manufacturer
    ISOTIS ORTHOBIOLOGICS, INC
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THERE APPEARED TO BE MOLD PRESENT ON THE PRODUCT, AND THAT THE PRODUCT HAD NOT BEEN OPENED. THE PRODUCT WAS NOT USED. THERE WAS NO ADVERSE OUTCOME FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBP PUTTY 5CC NA MQV ISOTIS ORTHOBIOLOGICS, INC 110343

    Patients

    Seq Age Sex Outcome Treatment
    1