DIAMOND TOUCH SILICONE SHEETING
Received Jun 25, 2001 · Event occurred Jun 15, 2001
Report 1221601-2001-00001 · MDR key 339446
Device
Generic name
Silicone Sheeting
Manufacturer
Genzyme Biosurgery A Div Of GeModel number
89-8529Catalog number
89-8529
Lot number
21265E
Product problems
- Reaction
Patient
UNKNOWN
- Allergic reaction
- Erythema
- Rash
- Skin Irritation
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
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.