BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIAMOND TOUCH SILICONE SHEETING

    MDR report key: 339446 · Received June 25, 2001

    Report

    Report Number
    1221601-2001-00001
    Event Type
    Other
    Date Received
    June 25, 2001
    Date of Event
    June 15, 2001
    Report Date
    June 25, 2001
    Manufacturer
    GENZYME BIOSURGERY A DIV OF GE
    Product Code
    MDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT ALLEGED AN ALLERGIC REACTION FOLLOWING THE USE OF SILICONE SHEETING. THE SILICONE SHEETING WAS USED TO TREAT HEAT BURNS WITH SCARRING. THE PRODUCT HAD BEEN USED SINCE 2000 WITHOUT COMPLICATION. FOLLOWING 30 HRS OF CONTINUOUS USE, THE COMPLAINANT ALLEGED EXPERIENCING A SEVERE RASH (ALL RED) AND ROUGH SKIN WHICH WAS FLAKING. IN ADDITION, THREE OF THE FOUR WOUND AREAS WERE PROPERLY HEALED PRIOR TO INITIAL APPLICATION; THE FOURTH STILL EXHIBITING REDNESS. THE FOURTH AREA WAS THE FIRST AREA TO SHOW SIGNS OF THE REPORTED REACTION, WITH THE REMAINING AREAS FOLLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28796 DIAMOND TOUCH SILICONE SHEETING SILICONE SHEETING MDA GENZYME BIOSURGERY A DIV OF GE 89-8529 21265E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other