FDA Adverse Event
Injury
Summary report: N
CAVICIDE1
MDR report key: 3261985
·
Received August 2, 2013
Report
- Report Number
- 1722021-2013-00018
- Event Type
- Injury
- Date Received
- August 2, 2013
- Report Date
- July 17, 2013
- Manufacturer
- METREX RESEARCH
- Product Code
- LRJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- MEDICAL ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
THE EMPLOYEE HAD SOUGHT MEDICAL ATTENTION WITH A GENERAL PHYSICIAN AND REFERRED TO AN ALLERGIST. THE EMPLOYEE HAS COMPLETED AN ALLERGY TEST; HOWEVER, NO ALLERGIES WERE DETERMINED. THE EMPLOYEE WAS PRESCRIBED FLONAZE AND EYE DROPS. TO DATE, THE EMPLOYEE IS FEELING BETTER. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS; THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS AND ACCEPTABLE PARAMETERS.
Description of Event or Problem · 1
A COMPLAINANT ALLEGED THAT ONE (1) EMPLOYEE HAS EXPERIENCED A REACTION WITH SYMPTOMS OF COUGHING, EYE DRAINAGE, AND A REACTIVE AIRWAY AFTER THE FACILITY UNKNOWING REFILLED CAVICIDE1 INTO CAVICIDE SPRAY BOTTLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362835 | CAVICIDE1 | SURFACE DISINFECTANT | LRJ | METREX RESEARCH | 12-2125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other| R | CAVICIDE |