BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILVERLON

    MDR report key: 372144 · Received January 16, 2002

    Report

    Report Number
    MW1023854
    Event Type
    Other
    Date Received
    January 16, 2002
    Date of Event
    January 15, 2002
    Report Date
    January 16, 2002
    Manufacturer
    *
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAS CHRONIC RIGHT LOWER EXTREMITY WOUND. WOUND DRESSING IS SILVERLON. PT WAS SENT TO MRI - R/O OSTEOMYELITIS, SILVERLON DRESSING WENT INTO MRI SCAN WITH THE PT AND THE PT EXPERIENCED SEVERE BURNING PAIN AT WOUND/DRESSING SITE DURING THE SCAN. PAIN RESOLVED AFTER THE SCAN WAS COMPLETED. WOUND WAS CHECKED AND NO SIGN OF THERMAL INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERLON CONTACT WOUND DRESSING FRO * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other MRI