MAUDE Adverse Event Report: HANDICARE HANDICARE; A450 LIFT

Model Number	324200
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Care worker injured by carry bar free falling from overhead lift.
Additional Manufacturer Narrative
Incident was reported because we believed that recurrence could cause a serious injury.Upon investigation, we determined that the incident would not be able to occur during use with weight.Therefore, the chance of recurrence causing a serious injury is remote to none.

• Brand Name: HANDICARE
• Common Device Name: A450 LIFT
• Manufacturer (Section D): HANDICARE; 10888 metro ct.; maryland heights MO 63043
• Manufacturer (Section G): HANDICARE; 10888 metro ct.; maryland heights MO 63043
• Manufacturer Contact: lauren stover ; 10888 metro ct.; maryland heights, MO 63043
• MDR Report Key: 19243926
• Report Number: 3007802293-2024-00004
• Device Sequence Number: 7107835
• Product Code: FSA
• UDI-Device Identifier: 00810045510996
• UDI-Public: 00810045510996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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
• Device Model Number: 324200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female