FDA Adverse Event
Summary report: N
CEVICIDE
MDR report key: 2003178
·
Received February 24, 2011
Report
- Report Number
- 2003178
- Date Received
- February 24, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 24, 2011
- Manufacturer
- METREX INC. 800-841-1428
- Product Code
- LRJ
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
STERILE PROCESSING STAFF REPORTED THAT THE PRODUCT CAVICIDE HAD AN UNUSUALLY STRONG ODOR. FOUR TO FIVE STAFF MEMBERS ON DIFFERENT SHIFTS NOTED THIS. THREE STAFF MEMBERS COMPLAINED OF NOT FEELING WELL (UNAWARE IF THERE WAS TREATMENT), WITH USE OF THE PRODUCT. STAFF ALSO NOTED OTHER PRODUCT WITH DIFFERENT LOT NUMBER NOT TO BE THE SAME.======================MANUFACTURER RESPONSE FOR CAVICIDE FORMULA, CAVICIDE======================MANUFACTURER VERIFIED THERE IS A CHANGE IN FORMULA. THE PRODUCT WAS SCENTED IN "WINTER MINT". THAT CHEMICAL DISCONTINUED, SO THEY HAVE EITHER FRAGRANCE FREE OR SPRING FRESH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CEVICIDE | CAVICIDE FORMULA | LRJ | METREX INC. 800-841-1428 | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |