FDA Adverse Event
Other
Summary report: N
CAREONE
MDR report key: 3772089
·
Received April 11, 2014
Report
- Report Number
- 1038758-2014-00008
- Event Type
- Other
- Date Received
- April 11, 2014
- Report Date
- April 10, 2014
- Manufacturer
- ASO LLC
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ON (B)(4) 2013 - THE CONSUMER REPORTED REDNESS, SWELLING AND SKIN PEELING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221595 | CAREONE | PLASTIC WATERPROOF STRONG STRIPS 1" 20 CT | KGX | ASO LLC | CAR1775 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |