FDA Adverse Event
Other
Summary report: N
TRANSPARENT DRESSING
MDR report key: 2987927
·
Received February 21, 2013
Report
- Report Number
- 1836161-2013-00031
- Event Type
- Other
- Date Received
- February 21, 2013
- Date of Event
- September 17, 2010
- Report Date
- February 21, 2013
- Manufacturer
- ASPEN SURGICAL PRODUCTS, INC.
- Product Code
- NAD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED AND NO TESTING PERFORMED. NO RESULTS AVAILABLE AS NO EVAL PERFORMED. IT WAS DETERMINED THAT THE ORIGINAL COMPLAINT WAS NOT CORRECTLY RECORDED. THE PROBLEM WAS INVOLVING PRODUCT SPECIFICATIONS.
Description of Event or Problem · 1
MULTIPLE REPORTS OF SKIN IRRITATION FROM PTS AFTER USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75479 | TRANSPARENT DRESSING | TRANSPARENT DRESSING | NAD | ASPEN SURGICAL PRODUCTS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |