MAUDE Adverse Event Report: HANDICARE UK LTD HANDICARE; 950 STAIRLIFT

Model Number 950

Device Problem Fracture (1260)

Patient Problem Death (1802)

Event Date 04/13/2020

Event Type  Death  

Event Description

An end user fell from the stairlift.The stairlift arm was broken.

• Brand Name: HANDICARE
• Type of Device: 950 STAIRLIFT
• Manufacturer (Section D): HANDICARE UK LTD; 82 first avenue; pensnett estate; kingswinford, dudley DY6 7 FJ; UK DY6 7FJ
• MDR Report Key: 10036561
• MDR Text Key: 190298603
• Report Number: 3007802293-2020-00008
• 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: 04/17/2020,05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 950
• Device Catalogue Number: ONAPPPLMS2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2020
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization