MAUDE Adverse Event Report: HANDICARE HANDICARE; C450 MANUAL TRAVERSE

Model Number 323101

Device Problems Component Missing (2306); Component Misassembled (4004)

Patient Problem Abrasion (1689)

Event Date 06/30/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 319831860
• Report Number: 3007802293-2023-00001
• Device Sequence Number: 1
• Product Code: FSA
• UDI-Device Identifier: 00810045510453
• UDI-Public: 00810045510453
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 323101
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female