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

Model Number HFK-9232

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

Patient was using the walker on uneven pavement when the sidewalk "went down" and the walker leg bent, the user fell and fractured a rib.Attention was not sought immediately but later in the day she went to the er.They did not keep her but informed her that the broken rib would take some time to heal.Released with pain meds and incentive spirometer.Patient is over the weight limit for use and environmental conditions may be contributory to event.Mdr is being filed in an abundance of caution.

• Brand Name: 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: 16335489
• MDR Text Key: 309158087
• Report Number: 1056127-2023-00003
• 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: 02/09/2023,02/06/2023

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: W1631R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2023
• Distributor Facility Aware Date: 02/06/2023
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 02/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 138 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American