MAUDE Adverse Event Report: INVAMEX PATIENT LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number	NA:9805P
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is being filed in an abundance of caution.There was no indication of patient involvement with this incident.The photo provided shows the bent leg does not make contact with the ground, which would result in instability of the lift.It is unclear if the bent leg resulted from a device malfunction or use error/physical damage.Attempts were made to try and obtain additional information.If additional information should become available, updates will be made accordingly.
Event or Problem Description
The consumer reported that one side of the leg bent after just 4 uses on a lift that was less than 2 years old.

• Brand Name: PATIENT LIFT
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 22666785
• Report Number: 9616091-2025-00011
• Device Sequence Number: 7607711
• Product Code: FSA
• UDI-Device Identifier: 00841447102465
• UDI-Public: 00841447102465
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: NA:9805P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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