FDA Adverse Event Injury Summary report: N

CAVICIDE

MDR report key: 3761550 · Received April 21, 2014

Report

Report Number
1722021-2014-00008
Event Type
Injury
Date Received
April 21, 2014
Date of Event
April 3, 2014
Report Date
April 3, 2014
Manufacturer
METREX RESEARCH
Product Code
LRJ
PMA / PMN Number
K951123
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NV, US
Reporter Occupation
PATIENT

Narratives

Additional Manufacturer Narrative · 1

NO CATALOG NUMBER, LOT NUMBER, OR EXPIRATION DATE WAS PROVIDED; THEREFORE, NO INFORMATION COULD BE PROVIDED. IT WAS REPORTED THAT THE PATIENT HAD SOUGHT MEDICAL ATTENTION AT THE EMERGENCY ROOM AND WAS PRESCRIBED EYE DROPS. THE PATIENT HAD RETURNED TO THE OFFICE ON (B)(6) 2014, FOR A FOLLOW UP APPOINTMENT. THE DOCTOR TOLD HER TO FINISH TAKING HER PRESCRIPTION AND HER EYE WILL BE FINE. DURING A FOLLOW UP PHONE CALL WITH THE COMPLAINANT ON (B)(6) 2014, IT WAS REPORTED THAT TO DATE, SHE IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

Description of Event or Problem · 1

A COMPLAINANT ALLEGED THAT A DENTAL OFFICE WAS SPRAYING CAVICIDE AND SOME OF THE SOLUTION GOT ON HER FACE AND EYE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
239893 CAVICIDE SURFACE DISINFECTANT LRJ METREX RESEARCH

Patients

Seq Age Sex Outcome Treatment
1 71 YR Other| R