MAUDE Adverse Event Report: A & J HOLDING CO. LTD STELLA; ROLLATOR

Model Number CGR-STELLA23-RD

Device Problem Unintended Movement (3026)

Patient Problem Spinal Column Injury (2081)

Event Date 12/19/2019

Event Type  Injury  

Event Description

The user, (b)(6), was sitting on his rollator facing the sink and mirror in his bathroom; when he turned his head up to allow his aide to shave his neck, the back-support strap on the rollator detached from it, causing mr.(b)(6) to fall backwards onto the tile floor.This fall resulted in injuries and hospitalization.

• Brand Name: STELLA
• Type of Device: ROLLATOR
• Manufacturer (Section D): A & J HOLDING CO. LTD; no.1, ben tin; ben tsouh vill; hsi-ko, hsiang 52842 7; CH 528427
• MDR Report Key: 13417035
• MDR Text Key: 284824389
• Report Number: 9615410-2022-00001
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 01/18/2022

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: CGR-STELLA23-RD
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2022
• Device Age: 3 YR
• Event Location: Nursing Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White