MAUDE Adverse Event Report: ACCUTRON, INC. FLOWMETER, DIGITAL FLUSHMOUNT

Model Number	27076
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nausea (1970)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Distributor reported that digital ultra is making patients sick.

• Brand Name: FLOWMETER, DIGITAL FLUSHMOUNT
• Common Device Name: FLOWMETER
• Manufacturer (Section D): ACCUTRON, INC.; 1625 w pinnacle peak rd; phoenix AZ 85027
• Manufacturer (Section G): ACCUTRON, INC.; 1625 w pinnacle peak rd; phoenix AZ
• Manufacturer Contact: stephanie wasielewski ; 1625 w pinnacle peak rd; phoenix, AZ 85027 ; 8472574500
• MDR Report Key: 22770442
• Report Number: 2020813-2025-00006
• Device Sequence Number: 21185026
• Product Code: BSZ
• UDI-Device Identifier: 00813830020885
• UDI-Public: (01)00813830020885
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 27076
• Device Catalogue Number: 27076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown