MAUDE Adverse Event Report: UNOMEDICAL A/S UNKNOWN

Model Number	UNKNOWN
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Request was performed for additional information including lot number; however, lot number was not provided.A complaint investigation was initiated under complaint investigation.Unfortunately, no specific lot number was identified, which limits the ability to trace or analyze a particular item.Investigation in progress.
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that the nurse did the priming of the tubing differently, possibly by pushing the plunger of the syringe.Patient advised the nurse to perform it as per the procedure.The patient had tremors and was shaking more since pump rate changed, hence dose was adjusted accordingly.No further information available.

• Brand Name: UNKNOWN
• Common Device Name: UNKNOWN
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 24742563
• Report Number: 8021545-2026-03102
• Device Sequence Number: 9049797
• Product Code: FPA
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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
• Patient Sex: Unknown