MAUDE Adverse Event Report: Savaria Concord Lifts Savaria; M-CLIN 2F 272 KG DLU WG NA

Model Number	M2F272-1002-02-NA
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction

• Brand Name: Savaria
• Common Device Name: M-CLIN 2F 272 KG DLU WG NA
• Manufacturer (Section D): Savaria Concord Lifts; 1625 boul. industriel; magog, quebec J1X5B 3; CA J1X5B3
• Manufacturer (Section G): Savaria Patient Care; 1625 boul. industriel; magog, quebec J1X 5 B3; CA J1X 5B3
• Manufacturer Contact: laetitia boisteau ; 1625 boul. industriel; magog, quebec J1X 5-B3 ; CA J1X 5B3
• MDR Report Key: 50164822
• Report Number: 3013169808-2026-00001
• Device Sequence Number: 14772016
• Product Code: FSA
• UDI-Device Identifier: 10688503001549
• UDI-Public: 10688503001549
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M2F272-1002-02-NA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown