BEUDAMED
    FDA Adverse Event Other Summary report: N

    DBP PUTTY 1CC

    MDR report key: 2111089 · Received May 24, 2011

    Report

    Report Number
    2090010-2011-00011
    Event Type
    Other
    Date Received
    May 24, 2011
    Date of Event
    March 21, 2011
    Report Date
    May 24, 2011
    Manufacturer
    INTEGRA, IRVINE
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PRODUCT WAS IMPLANTED DURING SINUS LIFT SURGERY, INFECTION WAS REPORTED. THE PRODUCT WAS OBSERVED TO HAVE "TURNED TO MUSH" AND WAS EXPLANTED. INTEGRA HAS REQUESTED IN WRITING, ADD'L CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBP PUTTY 1CC NA MQV INTEGRA, IRVINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCELL