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