FDA Adverse Event
Other
Summary report: N
SOOTHING NON-STICK DRESSING
MDR report key: 1885007
·
Received October 22, 2010
Report
- Report Number
- 3007663067-2010-00007
- Event Type
- Other
- Date Received
- October 22, 2010
- Date of Event
- September 24, 2010
- Report Date
- September 27, 2010
- Manufacturer
- SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED
- Product Code
- FRO
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: (B)(4) 2010. (B)(4). THE COMPLAINT IS REGARDING A PRODUCT MARKETED BY A THIRD PARTY; THE BRAND NAME OF THE PRODUCT IN QUESTION IS LISTED. THE PRODUCT IS IDENTICAL TO THE PRODUCT MARKETED BY THE MANUFACTURER UNDER THEIR OWN BRAND NAME (NOT INCLUDED IN THIS REPORT). IT IS THE RESPONSIBILITY OF THE MANUFACTURER TO SUBMIT MEDWATCH REPORTS FOR EITHER PRODUCT.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE DRESSING WAS EXTREMELY HARD TO REMOVE AND HAD TO GO TO THE DOCTOR TO GET IT REMOVED. THE DOCTOR HAD TO SOAK IT OFF, VERY PAINFUL AND TIME CONSUMING. NO OTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOOTHING NON-STICK DRESSING | DRESSING, SURGICAL WOUND, NON-ADHERING | FRO | SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LIMITED | 104029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |