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 |