FDA Adverse Event
Malfunction
Summary report: N
EQUOS BORDERED GAUZE 4X10
MDR report key: 2466053
·
Received February 9, 2012
Report
- Report Number
- 3006475494-2012-00004
- Event Type
- Malfunction
- Date Received
- February 9, 2012
- Date of Event
- September 1, 2011
- Report Date
- September 8, 2012
- Manufacturer
- BRADY TECHNOLOGY WUXI CO. LTD.
- Product Code
- KGX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L DEVICE MFR DATE: 10/13/2010.
Description of Event or Problem · 1
PTS GOT SKIN IRRITATION AND BLISTERS FROM THE ADHESIVE ON THE BANDAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EQUOS BORDERED GAUZE 4X10 | BORDERED GAUZE BANDAGE 4X10 | KGX | BRADY TECHNOLOGY WUXI CO. LTD. | 19381780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |