MAUDE Adverse Event Report: COM-BRIDGE INTERNATIONAL CO. LTD. ENDURANCE; QUAD CANE

Model Number ST801-CBL

Device Problem Fracture (1260)

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

Event Date 03/12/2023

Event Type  malfunction  

Event Description

End user was returning to his home when the shaft of the quad cane broke.No injury.

• Brand Name: ENDURANCE
• Type of Device: QUAD CANE
• Manufacturer (Section D): COM-BRIDGE INTERNATIONAL CO. LTD.; unit 1, no. 66, yulong 3 road; dong sheng town; zhong shan city, guangdong, 52841 4; CH 528414
• MDR Report Key: 16643646
• MDR Text Key: 312316215
• Report Number: 1056127-2023-00005
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00754756913014
• UDI-Public: 754756913014
• 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: 03/30/2023,03/22/2023

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: ST801-CBL
• Device Catalogue Number: W1301BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2023
• Distributor Facility Aware Date: 03/22/2023
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 03/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 92 YR
• Patient Sex: Male
• Patient Weight: 59 KG