FDA Adverse Event
Injury
Summary report: N
ADAPTIC TOUCH NON-ADHERING SILICONE DRESSING
MDR report key: 4331700
·
Received December 3, 2014
Report
- Report Number
- 3007663067-2014-00003
- Event Type
- Injury
- Date Received
- December 3, 2014
- Date of Event
- September 8, 2014
- Report Date
- October 30, 2014
- Manufacturer
- SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
- Product Code
- FRO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DRESSING WAS NOT RETURNED TO SYSTAGENIX FOR EVALUATION NOR HAS A LOT NUMBER OF THE DRESSING BEEN PROVIDED. BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED MACERATION WAS RELATED TO ADAPTIC TOUCH NON-ADHERING SILICONE DRESSING.
Description of Event or Problem · 1
ON (B)(6) 2014, THE FOLLOWING INFORMATION WAS REPORTED TO SYSTAGENIX BY THE CLINICIAN: THE CLINICIAN ALLEGEDLY OBSERVED " A LOT OF EXUDATE VISIBLE BENEATH THE MESH. THE EXUDATE WAS PREVENTED TO MOVE UPWARDS INTO THE SECONDARY DRESSING DUE TO SMALL HOLES IN THE MESH". ALLEGEDLY, DUE TO "LACK OF EVACUATION OF FLUIDS JAMMED INTO THE WOUND GROUND", THE WOUND BECAME MACERATED. MECHANICAL DEBRIDEMENT WAS PERFORMED ON THE "SEVERELY LIVID" MACERATED SKIN. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779521 | ADAPTIC TOUCH NON-ADHERING SILICONE DRESSING | FRO | SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |