FDA Adverse Event
Injury
Summary report: N
LIVONGO BLOOD PRESSURE MONITOR
MDR report key: 20201325
·
Received September 12, 2024
Report
- Report Number
- 3011196194-2024-00049
- Event Type
- Injury
- Date Received
- September 12, 2024
- Date of Event
- August 29, 2024
- Report Date
- September 11, 2024
- Manufacturer
- TELADOC 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 INCIDENT WAS NOT RETURNED FOR INVESTIGATION. IF THE DEVICE IS RETURNED, AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
THE PATIENT REPORTED THAT THEIR CUFF WAS TOO SMALL AND CAUSED DISCOLORATION. TELADOC'S BLOOD PRESSURE MONITOR FITS PATIENTS WITH UP TO A 42CM ARM CIRCUMFERENCE, THE PATIENT CONFIRMED THAT THEIR ARM IS LARGER THAN 42CM. THE PATIENT CONFIRMED THAT THEY ARE NOT TAKING MEDICATION THAT COULD CONTRIBUTE TO BRUISING. IT WAS NOT CONFIRMED IF THE PATIENT RECEIVED MEDICAL ATTENTION DUE TO THE DISCOLORATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622552 | LIVONGO BLOOD PRESSURE MONITOR | BLOOD PRESSURE MONITOR | DXN | TELADOC HEALTH, INC. | HT900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Unknown | Other |