BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUOSS XC

    MDR report key: 3177544 · Received June 8, 2013

    Report

    Report Number
    2249852-2013-00003
    Event Type
    Other
    Date Received
    June 8, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPM
    PMA / PMN Number
    K043034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CLAIMS THAT HIVES DEVELOPED ON NECK, CHEST, AND ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259151 NUOSS XC BONE GRAFTING MATERIAL NPM COLLAGEN MATRIX, INC. 509-2001 BMCPU09M1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other