FDA Adverse Event
Injury
Summary report: N
FLOWMETER, DIGITAL FLUSHMOUNT
MDR report key: 22770442
·
Received August 11, 2025
Report
- Report Number
- 2020813-2025-00006
- Event Type
- Injury
- Date Received
- August 11, 2025
- Date of Event
- July 31, 2025
- Report Date
- August 11, 2025
- Manufacturer
- ACCUTRON, INC.
- Product Code
- BSZ
- UDI-DI
- 00813830020885
- PMA / PMN Number
- K052335
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A COMPLETE AND THOROUGH TEST AND EVALUATION WAS CONDUCTED OF THIS UNIT IN AS RECEIVED CONDITION AND COULD NOT DUPLICATE REPORTED PROBLEM. UNIT MEETS FACTORY SPECIFICATIONS.
Description of Event or Problem · 0
DISTRIBUTOR REPORTED THAT DIGITAL ULTRA IS MAKING PATIENTS SICK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2003154 | FLOWMETER, DIGITAL FLUSHMOUNT | FLOWMETER | BSZ | ACCUTRON, INC. | 27076 | 00813830020885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |