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

Model Number HFK-9232

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

Patient was using the walker in home to go to the bathroom.She sat on the walker and the right rear leg broke.No fall or injury.

• Brand Name: FEATHERLIGHT
• 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: 17125801
• MDR Text Key: 317166400
• Report Number: 1056127-2023-00007
• 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: Other
• Type of Report: Initial
• Report Date: 06/14/2023,06/13/2023

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2023
• Distributor Facility Aware Date: 06/13/2023
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 06/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 89 KG