FDA Adverse Event
Malfunction
Summary report: N
VARIOUS
MDR report key: 555893
·
Received August 21, 2004
Report
- Report Number
- MW1033351
- Event Type
- Malfunction
- Date Received
- August 21, 2004
- Date of Event
- July 1, 2004
- Report Date
- August 21, 2004
- Manufacturer
- *
- Product Code
- CBF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
RPTR WANTS TO KNOW THE FDA'S POSITION ON HBOT - HYPERBARIC OXYGEN THERAPY. MANY PHYSICIANS AND TREATMENT FACILITIES SAY IT IS QUACKERY, OTHERS SAY IT IS "GOD'S LATEST GIFT TO MEDICINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VARIOUS | HYPERBARIC OXYGEN CHAMBER | CBF | * | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |