FDA Adverse Event
Other
Summary report: N
CIDEX OPA SOLUTION
MDR report key: 624086
·
Received August 3, 2005
Report
- Report Number
- 2084725-2005-00214
- Event Type
- Other
- Date Received
- August 3, 2005
- Report Date
- March 23, 2001
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- LRJ
- Removal / Correction Number
- Z0051-05
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FACILITY REPORTS STAFF HAVING HEADACHES ASSOCIATED WITH OPA USE. SOME ALSO COMPLAINED OF BREATHING PROBLEMS. NO INDIVIDUAL SPECIFIC INFO PROVIDED. NO MEDICAL TREATMENT SOUGHT. NEW CUSTOM ULTRASONIC PROCESSORS AND BETTER VENTILATION SOLVED THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIDEX OPA SOLUTION | DISINFECTANT | LRJ | ADVANCED STERILIZATION PRODUCTS | 20390 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |