FDA Adverse Event
Injury
Summary report: N
LIVONGO BLOOD PRESSURE MONITOR
MDR report key: 16000554
·
Received December 16, 2022
Report
- Report Number
- 3011196194-2022-00033
- Event Type
- Injury
- Date Received
- December 16, 2022
- Date of Event
- November 17, 2022
- Report Date
- November 30, 2022
- Manufacturer
- LIVONGO HEALTH INC
- Product Code
- DXN
- PMA / PMN Number
- K131395
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE ASSOCIATED WITH THIS EVENT WAS RETURNED TO THE MANUFACTURER AND UNDERWENT TESTING. THE TESTING DID NOT REVEAL ANY ISSUES WITH THE DEVICE, AS THE DEVICE PERFORMED AS INTENDED. THE REPORTED EVENT OF THE CUFF OVERINFLATING WAS UNABLE TO BE REPRODUCED.
Description of Event or Problem · 0
THE MEMBER REPORTED THAT WHILE USING THEIR LIVONGO BLOOD PRESSURE MONITOR THE MONITOR BECAME TOO TIGHT AND LEFT CONTUSIONS ON THEIR ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2589892 | LIVONGO BLOOD PRESSURE MONITOR | BLOOD PRESSURE MONITOR | DXN | LIVONGO HEALTH INC | HT900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Unknown | Other |