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

Model Number HFK-9232

Device Problem Crack (1135)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

Patient was holding onto the handles of her rollator and trying to get up from her wheelchair when the rear leg sapped in half just below the seat.She lost her balance but her son caught her from falling.No injury occurred.

• Brand Name: THE BLAZER
• 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: 15734760
• MDR Text Key: 303077173
• Report Number: 1056127-2022-00012
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756360771
• UDI-Public: 754756360771
• 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: 11/04/2022,10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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: W1631R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2022
• Distributor Facility Aware Date: 10/13/2022
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 11/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White