PROVOX SILICONE GLUE
Received Nov 25, 2015
Report 8032044-2015-00009 · MDR key 5249521
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burn(s)
Narrative
Additional Manufacturer Narrative
THE SILICONE GLUE WAS INVESTIGATED. NOTHING STRANGE WAS FOUND AND GLUE HAD A FULL FUNCTIONALITY. THE VISCOSITY OF THE GLUE WAS FOUND TO BE NORMAL. PATIENT PHOTO SHOWS SKIN IRRITATION/DISCOMFORT AROUND THE STOMA. REACTIONS TO ADHESIVES SOMETIMES OCCUR. IN MANUAL UNDER CAUTION, IT CAN BE READ HOW TO DO WHEN THE USER HAS SKIN IRRITATION OR OTHER DISCOMFORT. CONCLUSION: NO PRODUCT ERROR. INFORM THE USER NOT TO USE THE PRODUCT WHEN SKIN IRRITATION OR OTHER DISCOMFORT OCCURS.
Description of Event or Problem
AFTER USING THE GLUE THE PATIENT FELT THAT IT WAS BURNING ON HER SKIN. THE GLUE WAS MORE VISCOUS THAN THE OTHER GLUE SHE HAD BEFORE. THE PATIENT HAS A "BURN" WOUND.