MAUDE Adverse Event Report: ACORN STAIRLIFTS ACORN RET 130 RH USA; POWERED STAIRLIFT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 07/01/2022

Event Type  Injury  

Event Description

Customer reported that she use the stairlifts to go down the stair and thought that she has reach the bottom of the stair.She proceed to get out and realise she was only halfway down.She fell down the rest of the way.She dislocated her collar bone, pain on her right hip and right arm.She spend time in hospital.

• Brand Name: ACORN RET 130 RH USA
• Type of Device: POWERED STAIRLIFT
• Manufacturer (Section D): ACORN STAIRLIFTS; 7001 lake ellenor dr; orlando FL 32809 5792
• Manufacturer (Section G): ACORN STAIRLIFTS; 7001 lake ellenor dr; orlando FL 32809 5792
• Manufacturer Contact: amanda stahl ; 7001 lake ellenor dr; orlando, FL 32809-5792 ; 4076500216
• MDR Report Key: 17415432
• MDR Text Key: 319960810
• Report Number: 3003124453-2023-00014
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/28/2023

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 Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: WALKER, CANE
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 92 KG