FDA Adverse Event
Malfunction
Summary report: N
REGARD
MDR report key: 23707055
·
Received December 3, 2025
Report
- Report Number
- 3004513970-2025-00013
- Event Type
- Malfunction
- Date Received
- December 3, 2025
- Date of Event
- November 4, 2025
- Report Date
- December 3, 2025
- Manufacturer
- RESOURCE OPTIMIZATION & INNOVATION, LLC
- Product Code
- DXQ
- UDI-DI
- 10326053121569
- PMA / PMN Number
- K921997
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
A CUSTOMER REPORTED THAT THE BLOOD PRESSURE CUFF OVERINFLATED, CAUSED PAIN, BRUISING, AND DISPLAYED AN INCORRECT READING WHEN ATTEMPTING TO TAKE A BLOOD PRESSURE. THIS CAUSED THE BLOOD PRESSURE TO BE RETAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2787398 | REGARD | COMFORT CHECK DISPOSABLE BLOOD PRESSURE CUFF LARGE ADULT (33-41CM) | DXQ | RESOURCE OPTIMIZATION & INNOVATION, LLC | DBPLRGADLT-REG | UNKNOWN | 10326053121569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |