MAUDE Adverse Event Report: HANDICARE ACCESSIBILITY LTD. 1100 STRAIGHT STAIRLIFT; POWERED STAIRLIFT

Model Number 1100

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Insufficient Information (4580)

Event Date 09/30/2022

Event Type  Injury  

Event Description

The seat/footrest chassis of an 1100 detached from the powerpack, with the user on the lift.

• Brand Name: 1100 STRAIGHT STAIRLIFT
• Type of Device: POWERED STAIRLIFT
• Manufacturer (Section D): HANDICARE ACCESSIBILITY LTD.; 82 first avenue,; pensnett estate; kingswinford, dudley DY6 7 FJ; UK DY6 7FJ
• MDR Report Key: 15676654
• MDR Text Key: 302468809
• Report Number: 3011268530-2022-00001
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/26/2022

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 Operator: Lay User/Patient
• Device Model Number: 1100
• Device Catalogue Number: 1100
• Distributor Facility Aware Date: 09/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other