FDA Adverse Event
Other
Summary report: N
AQUA+ HCH
MDR report key: 258566
·
Received January 12, 2000
Report
- Report Number
- 2014730-2000-00001
- Event Type
- Other
- Date Received
- January 12, 2000
- Date of Event
- November 30, 1999
- Report Date
- January 7, 2000
- Manufacturer
- HUDSON RCI
- Product Code
- BYD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HCH HAD A BAD TASTE AND AN OFFENSIVE ODOR. PARENT REPORTED THAT CHILD'S SATURATION APPEARED LOWER, SO WAS TAKEN TO DOCTOR. FELT IT OCCURRED DUE TO SMELL OF HCH AND DISCONTINUED USE. PT SATURATION RETURNED TO PREVIOUS LEVELS SHORTLY AFTER WHEN HCH WITHOUT ODOR WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AQUA+ HCH | HYGROSCOPIC CONDENSER HUMIDIFIER (HCH) | BYD | HUDSON RCI | NA | 3-44910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Other |