FDA Adverse Event
Other
Summary report: N
CIDEX OPA SOLUTION
MDR report key: 625971
·
Received August 12, 2005
Report
- Report Number
- 2084725-2005-00175
- 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 EXPERIENCED A DEEP COUGH, SNEEZING, AND RED BURNING EYES AFTER WORKING WITH THE PRODUCT. THEY SOUGHT MEDICAL TREATMENT AND WAS GIVEN ZITHROMAX, AND INHALER, AND STEROIDS AFTER A CHEST XRAY. SYMPTOMS WOULD CLEAR AFTER SEVERAL DAYS OFF WORK. RESOLUTION OF PROBLEM WITH IMPROVEMENT OF THE VENTILATION SYSTEM AT WORK.
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 | 45 YR | Other |