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

Device Problem Break (1069)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 12/04/2019

Event Type  malfunction  

Event Description

Swivel motor actuator shaft broken, user fell down the stairs.

• Brand Name: FREECURVE
• Type of Device: STAIRLIFTS
• Manufacturer (Section D): HANDICARE STAIRLIFTS B.V; newtonstraat 35; p.o. box 39; heerhugowaard, 1700 AA; NL 1700 AA
• MDR Report Key: 9513101
• MDR Text Key: 204338878
• Report Number: 3007802293-2019-00048
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 12/23/2019

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1