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

Model Number W1301BL

Device Problem Fracture (1260)

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

Per caller, her grandfather was coming back in the house from taking out the recycling bin and it broke at the height adjustment knob.No injuries reported.He normally uses a walker but cane is used occasionally if he's only going outside for a few minutes.No further information available.Photos submitted.Requests replacement; will accept small base if that's all that's available.Grandfather has broken parts of cane.Spoke with complainant again.She felt that speaking with the patient, her grandfather, would not yield additional information about the incident or device.She had questioned him as to whether he had noticed any "weakness" in the cane prior to the incident and he had said no.She reports that the incident happened when he was returning from putting a small quantity of cans into the recycling.He was not moving or using a large bin.She confirmed the report that the cane shaft broke when he was walking.She will be returning the damaged cane when she receives the replacement.

• Brand Name: ENDURANCE
• Type of Device: CANE
• Manufacturer (Section D): COM-BRIDGE INTERNATIONAL CO.,LTD; no. 66, no. 62, no. 58, no. 52; yu long 3 road, dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• Manufacturer (Section G): COM-BRIDGE INTERNATIONAL CO.,LTD; no. 66, no. 62, no. 58, no. 52; yu long 3 road, dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 16641965
• MDR Text Key: 312293358
• Report Number: 3005739540-2023-00001
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2023

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: W1301BL
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 92 YR
• Patient Sex: Male
• Patient Weight: 59 KG