BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NU-GEL DRESSING 3.75 X 3.75

    MDR report key: 447997 · Received March 12, 2003

    Report

    Report Number
    MW1027836
    Event Type
    Malfunction
    Date Received
    March 12, 2003
    Date of Event
    February 7, 2003
    Report Date
    February 25, 2003
    Manufacturer
    JOHNSON & JOHNSON MEDICAL DIVISION OF ETHICON INC.
    Product Code
    MGQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 6/30/03: DEVICE INVOLVED IN REPORTED INCIDENT WAS DISCARDED AND UNAVAILABLE FOR EVALUATION INCLUDING ANY LABORATORY TESTING OR FAILURE ANALYSIS. THEREFORE NO CONCLUSIONS COULD BE REACHED IN REGARDS TO DEVICE FAILURE. DUE DILIGENCE FOLLOW-UP WAS CONDUCTED WITH REPORTER AND IT WAS DETERMINED THAT NU-GEL DRESSING WAS REMOVED FROM PT APPROX 10-15 MINUTES INTO THE MRI PROCEDURE DUE TO THE HEAT SENSATION. THE RN WHO REMOVED THE DRESSING DID NOT FEEL THAT THE DRESSING WAS "HOT" WHEN REMOVED. THE PT REQUIRED NO MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. ETHICON HAS NOT RECEIVED ANY ADD'L COMPLAINTS SIMILAR TO THIS INCIDENT.

    Description of Event or Problem · 1

    DURING MRI, PT DEVELOPED WARMTH THEN BURNING UNDER RIGHT BREAST. PT HAD DRESSING WITH GEL-PAD FOR SKIN BREAKDOWN. IMMEDIATELY REMOVED FROM SCANNER. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NU-GEL DRESSING 3.75 X 3.75 DRESSING MGQ JOHNSON & JOHNSON MEDICAL DIVISION OF ETHICON INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other