FDA Adverse Event
Injury
Summary report: N
PROVOX SILICONE GLUE
MDR report key: 5249521
·
Received November 25, 2015
Report
- Report Number
- 8032044-2015-00009
- Event Type
- Injury
- Date Received
- November 25, 2015
- Report Date
- November 25, 2015
- Manufacturer
- ATOS MEDICAL AB
- Product Code
- GBJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 780045 | PROVOX SILICONE GLUE | ADHESIVE GLUE | GBJ | ATOS MEDICAL AB | 1506120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |