FDA Adverse Event
Injury
Summary report: N
LIVONGO BLOOD PRESSURE MONITOR
MDR report key: 19842794
·
Received July 26, 2024
Report
- Report Number
- 3011196194-2024-00037
- Event Type
- Injury
- Date Received
- July 26, 2024
- Date of Event
- July 10, 2024
- Report Date
- July 26, 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 REQUESTED FOR RETURN FOR INVESTIGATION DUE TO THE PATIENT CONFIRMING THAT THE DEVICE'S CUFF IS TOO SMALL.
Description of Event or Problem · 0
THE PATIENT REPORTED THAT THEIR CUFF CONTINUED TO INFLATE TO THE POINT OF BRUISING THEIR ARM. TELADOC'S BLOOD PRESSURE MONITOR FITS PATIENTS WITH UP TO A 45CM ARM CIRCUMFERENCE, THE PATIENT CONFIRMED THAT THEIR ARM IS LARGER THAN 45CM. THE PATIENT DID NOT SEEK MEDICAL ATTENTION DUE TO THE BRUISING FROM THEIR CUFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 883473 | LIVONGO BLOOD PRESSURE MONITOR | BLOOD PRESSURE MONITOR | DXN | TELADOC HEALTH, INC. | HT945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Unknown | Other |