FDA Adverse Event
Injury
Summary report: N
GRAND DRIVE VERTICAL 1.3 ATA
MDR report key: 2682191
·
Received July 31, 2012
Report
- Report Number
- MW5026363
- Event Type
- Injury
- Date Received
- July 31, 2012
- Date of Event
- July 17, 2012
- Report Date
- July 31, 2012
- Manufacturer
- CERTEC/SUMMIT TO SEA
- Product Code
- CBF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GRAND DRIVE VERTICAL 1.3 ATA | PORTABLE HYPERBARIC CHAMBER | CBF | CERTEC/SUMMIT TO SEA | GRAND DRIVE VERTICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |