MAUDE Adverse Event Report: HANDICARE HANDICARE; C450 MANUAL TRAVERSE

Model Number	323101
Medical Device Problem Codes	Component Missing (2306); Component Misassembled (4004)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Motor came out of the end of the track when the care aid was returning the motor to the docking station.The motor hit the care aid causing bruising on the back of right hand and knee, no hospitalization.Employee put ice on the area and was able to keep working for her entire shift.Upon inspection of the track, there were no safety pins installed.

• Brand Name: HANDICARE
• Common Device Name: C450 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
• MDR Report Key: 17402284
• Report Number: 3007802293-2023-00001
• Device Sequence Number: 7493806
• Product Code: FSA
• UDI-Device Identifier: 00810045510453
• UDI-Public: 00810045510453
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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: 323101
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female