FDA Adverse Event
Injury
Summary report: N
SHOPKO
MDR report key: 4122378
·
Received September 18, 2014
Report
- Report Number
- 1038758-2014-00026
- Event Type
- Injury
- Date Received
- September 18, 2014
- Report Date
- September 17, 2014
- Manufacturer
- ASO LLC
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ON (B)(6) 2014 - PRODUCT CAUSED RASH, TORE SKIN AND LEFT A SCAR AROUND AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 579153 | SHOPKO | ADHESIVE BANDAGE | KGX | ASO LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |