MAUDE Adverse Event Report: HANDICARE HANDICARE; C-625 MANUAL TRAVERSE

Model Number	323117
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A basic tabletop function test was performed and it was found that the lift functioned fine, but had signs of strap wear, wear marks in the plastic, loose motor bolts, no grease, cracked and broken covers, and a lot of debris in the lift.The condition this lift currently is in couldn't have occurred in the 8 months since the last preventive maintenance was performed, unless the maintenance was improperly performed or not performed at all.A weight test was performed and the investigator was unable to exactly replicate the failure the (b)(6) reported.
Event or Problem Description
We had one of our 625lb handicare ceiling lifts that was holding the vet approximately 18 inches above a toilet when the strap suddenly dropped.The strap is intact but sounds like it slipped, dropping the vet back onto the toilet.The vet was transported to the hospital with a fracture.

• Brand Name: HANDICARE
• Common Device Name: C-625 MANUAL TRAVERSE
• 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: 24022780
• Report Number: 3007802293-2025-00010
• Device Sequence Number: 13441667
• Product Code: FSA
• UDI-Device Identifier: 00810045510484
• UDI-Public: 00810045510484
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: 323117
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2018
• 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: Male
• Patient Weight: 91 KG