MAUDE Adverse Event Report: FOSHAN HUAFUKANG MEDICAL TECHNOLOGY CO LTD FEATHERLIGHT WALKER; ROLLATOR

Model Number HFK-9232

Device Problem Device Slipped (1584)

Patient Problems Bruise/Contusion (1754); Pain (1994)

Event Date 02/10/2022

Event Type  malfunction  

Event Description

End user was sitting on rollator near the edge of a sidewalk when the device rolled backward and off sidewalk.User's husband believes the brake failed.When wheel rolled off, the leg snapped off, user landed on her side suffering soreness and bruising.No serious injury.

• Brand Name: FEATHERLIGHT WALKER
• Type of Device: ROLLATOR
• Manufacturer (Section D): FOSHAN HUAFUKANG MEDICAL TECHNOLOGY CO LTD; youhe industry area, luoxing; danzao town, nanhai district; foshan city, guangdong 52821 6; CH 528216
• MDR Report Key: 13666938
• MDR Text Key: 286641091
• Report Number: 1056127-2022-00002
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756360740
• UDI-Public: 754756360740
• 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: 03/04/2022,02/17/2022

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
• Device Model Number: HFK-9232
• Device Catalogue Number: W1651T
• Was Device Available for Evaluation?: No
• Date Report Sent to FDA: 03/04/2022
• Distributor Facility Aware Date: 02/17/2022
• Device Age: 5 MO
• Event Location: Other
• Date Report to Manufacturer: 03/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White