FDA Adverse Event
Other
Summary report: N
CVS
MDR report key: 2985480
·
Received February 26, 2013
Report
- Report Number
- 1038758-2013-00010
- Event Type
- Other
- Date Received
- February 26, 2013
- Date of Event
- June 22, 2012
- Report Date
- February 22, 2013
- Manufacturer
- ASO LLC
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED A REACTION AFTER USING CVS ADHESIVE PADS MEDIUM 2 1/4 INCHES X 3 INCHES AROUND WHERE THE ADHESIVE PART GOT IN CONTACT WITH HER SKIN. SHE HAS A RASH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 81038 | CVS | ADHESION BANDAGES | KGX | ASO LLC | 050428955543 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |