MAUDE Adverse Event Report: HANDICARE STAIRLIFTS B.V HANDICARE; 1100

Model Number	1100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
When the user was approximately half-way up the stairs, the seatbelt broke and the user fell from the seat.The user's father caught him, returned him to the seat, and continued the ride to the top of the stairs.The user was not injured.

• Brand Name: HANDICARE
• Common Device Name: 1100
• Manufacturer (Section D): HANDICARE STAIRLIFTS B.V; newtonstraat 35; p.o. box 39; heerhugowaard, noord-holland 1700 AA; NL 1700 AA
• MDR Report Key: 10065631
• Report Number: 3007802293-2020-00009
• Device Sequence Number: 3697027
• Product Code: PCD
• UDI-Device Identifier: 08719326254326
• UDI-Public: (01)08719326254326(11)191021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2020
• Report Date (Section F): 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1100
• Device Catalogue Number: AA17359
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2020
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 05/07/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 95
• Date Report Sent to FDA: 05/18/2020