FDA Adverse Event
Other
Summary report: N
CIDEX OPA SOLUTION
MDR report key: 629148
·
Received August 24, 2005
Report
- Report Number
- 2084725-2005-00165
- Event Type
- Other
- Date Received
- August 24, 2005
- Date of Event
- February 17, 2004
- Report Date
- February 17, 2004
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- LRJ
- Removal / Correction Number
- Z0051-05
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
CUSTOMER CALLS INDICATING CUSTOMER SENT 4 EMPLOYEES TO ER WITH FACIAL, NECK, AND BODY RASHES. THEY ARE ITCHING, PUFFY, BRIGHT RED LIKE WIND BURNED SKIN. ER DR DIAGNOSED AS ALLERGIC REACTION. NO KNOWN TREATMENT REC'D. NO USER SPECIFICS WERE REC'D FOR THIS INCIDENT.
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 |