FDA Adverse Event
Other
Summary report: N
CIDEX OPA SOLUTION
MDR report key: 625928
·
Received August 12, 2005
Report
- Report Number
- 2084725-2005-00176
- Event Type
- Other
- Date Received
- August 12, 2005
- Report Date
- August 26, 2004
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- LRJ
- Removal / Correction Number
- Z0051-05
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT HAS EXPERIENCED ACUTE EYE WATERING AND IRRITATION, ALSO SORES INSIDE THEIR LEFT NOSTRIL THAT LASTED TWO WEEKS. THEY DID NOT RECALL GETTING SPLASHED WITH PRODUCT BUT HAS BEEN WORKING WITH IT. THEY SOUGHT MEDICAL ATTENTION WITH AN ALLERGIST AND DERMATOLOGIST. STATES THEY ARE ALLERGIC TO GLUTARALDEHYDE TREATMENT IS UNKNOWN.
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 |