FDA Adverse Event
Other
Summary report: N
CIDEX PLUS 26 DAY SOLUTION
MDR report key: 625133
·
Received August 9, 2005
Report
- Report Number
- 2084725-2005-00258
- Event Type
- Other
- Date Received
- August 9, 2005
- Date of Event
- June 15, 2005
- Report Date
- June 21, 2005
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- LRJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A ANESTHEAIOLOGIST EXPERIENCED CHEST TIGHTNESS, EYE IRRITATION, AND IRRITATION IN THEIR THROAT WHEN EXPOSED TO CIDEX PLUS IN THE OPERATING ROOM. THE SYSMPTOMS RESOLVED IN 6-8 HOURS, AND THEY DID NOT SEEK MEDICAL ATTENTION. THE PHYSICIAN HAS WORKED IN THIS OR FOR 2 MONTHS AND WERE LATEX GLOVES, A FACE MASK, GOGGLES, AND A PROTECTIVE GOWN. SYMPTOMS HAVE SUBSIDED SINCE THEY STARTED TO WEAR A MASK DURING PROCEDURES AND THE CIDEX LUS WAS REMOVED FROM THE ROOM. THE PHYSICIAN HAS A POTENTIAL LATEX ALLERGY AND NOW IS WEARING SPECIALLY ORDERED POWDER FREE GLOVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIDEX PLUS 26 DAY SOLUTION | DISINFECTANT | LRJ | ADVANCED STERILIZATION PRODUCTS | 2785 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |