MAUDE Adverse Event Report: FOSHAN JOIN MEDICAL CO. LTD. THE BLAZER; WHEELED WALKER

Model Number JI-9023-BLUE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hip Fracture (2349)

Event Date 12/31/2016

Event Type  Injury  

Event Description

Patient attempted to rise from her recliner by grabbing one side of walker.The walker rotated causing her to be thrown forward and hitting the closet door.She reports that she tried to catch herself but her legs went in opposite directions and she fell breaking her hip.

• Brand Name: THE BLAZER
• Type of Device: WHEELED WALKER
• Manufacturer (Section D): FOSHAN JOIN MEDICAL CO. LTD.; 29th bldg, no. 1, liandu st; lielu town; shunde district, foshan, guangdong 52830 3; CH 528303
• MDR Report Key: 6354483
• MDR Text Key: 68179310
• Report Number: 1056127-2017-00006
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754756131081
• UDI-Public: 754756131081
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/23/2017,02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JI-9023-BLUE
• Device Catalogue Number: W1630B-12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2017
• Distributor Facility Aware Date: 02/08/2017
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 64