BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ESPE RELIX UNICEM APPLICAP/MAXICAP

    MDR report key: 1852921 · Received October 1, 2010

    Report

    Report Number
    MW5017633
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    3M
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED AN IMMEDIATE ALLERGIC REACTION AFTER PLACEMENT. IMPLANTATION, PAIN AND LEFT EAR PAIN. DISCOMFORT WHEN BLOWING NOSE. NO INFO ON PRODUCT GIVEN TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M ESPE RELIX UNICEM APPLICAP/MAXICAP PERMANENT CEMENT SELF ADHESIVE DYH 3M

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other