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

Model Number HFK-9232

Device Problem Crack (1135)

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

End user was rising from the toilet when the frame cracked/broke on the left rear side below seat crossbar weld.No ijury occurred.

• Brand Name: BLAZER 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: 15606956
• MDR Text Key: 301753831
• Report Number: 1056127-2022-00011
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756360764
• UDI-Public: 754756360764
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• 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: W1631BK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2022
• Distributor Facility Aware Date: 09/19/2022
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 10/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 85 KG