MAUDE Adverse Event Report: HANDICARE HANDICARE; INDEPENDENT LIFTER - MEDIUM LEG SUPPORT

Model Number	341610
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a leg spasm and fell from independent lifter while using without assistance, sustaining a leg fracture.According to the patient and onsite investigation, there was no device malfunction.

• Brand Name: HANDICARE
• Common Device Name: INDEPENDENT LIFTER - MEDIUM LEG SUPPORT
• 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 ; 3149436468
• MDR Report Key: 23057995
• Report Number: 3007802293-2025-00006
• Device Sequence Number: 18471778
• Product Code: FSA
• UDI-Device Identifier: 00810045511504
• UDI-Public: 00810045511504
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

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
• Device Model Number: 341610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown