FDA Adverse Event
Other
Summary report: N
HOMEDICS
MDR report key: 876643
·
Received June 11, 2007
Report
- Report Number
- 1832894-2007-00063
- Event Type
- Other
- Date Received
- June 11, 2007
- Date of Event
- January 10, 2007
- Report Date
- January 16, 2007
- Manufacturer
- ROSSMAX INTERNATIONAL LDT.
- Product Code
- DXN
- PMA / PMN Number
- K013539
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SEE ADDITIONAL SCANNED PAGES.
Description of Event or Problem · 1
CONSUMER TOOK TWO UNITS TO THE DOCTOR ON JANUARY 10, 2007. BOTH UNITS READ HIGH COMPARED TO THE DOCTOR'S READINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMEDICS | BLOOD PRESSURE MONITOR | DXN | ROSSMAX INTERNATIONAL LDT. | BPA-250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |