MAUDE Adverse Event Report: HANDICARE STAIRLIFTS B.V. HANDICARE; STAIR CHAIR LIFT

Model Number 1100

Device Problem Unintended Ejection (1234)

Patient Problem Fall (1848)

Event Date 08/09/2023

Event Type  Injury  

Event Description

It was reported that the user was attempting to sit on the unit and chair slide down the rail stairlift rail.The user was ejecting ejected from the chair onto the floor.His brother called an ambulance.User was reportedly admitted to hospital for 2 days and now out doing therapy.

Manufacturer Narrative

Unit will be brought back to distribution facility in canada for investigation.

• Brand Name: HANDICARE
• Type of Device: STAIR CHAIR LIFT
• Manufacturer (Section D): HANDICARE STAIRLIFTS B.V.; newtonstraat 35; po box 39; heerhugowaard, noord holland 1700 AA; NL 1700 AA
• MDR Report Key: 17836931
• MDR Text Key: 324511559
• Report Number: 3005753836-2023-00001
• Device Sequence Number: 1
• Product Code: PCD
• UDI-Device Identifier: 8719326254326
• UDI-Public: 018719326254326
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2023,09/27/2023

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: 1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2023
• Distributor Facility Aware Date: 09/08/2023
• Date Report to Manufacturer: 09/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male