MAUDE Adverse Event Report: COM-BRIDGE INTERNATIONAL CO.,LTD LARGE BASE QUAD CANE

Model Number W1302BL

Device Problem Break (1069)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

From complaint: end user is a truck driver and was in a pilot truck stop getting coffee when he said the cane felt odd.He started to walk and it just snapped in two, just under the curve of the handle.No injury reported.Labels wore off as end user takes cane in shower with him.He contacted binson's first but they advised him to contact us directly.Requested photos of both pieces of cane, included where it snapped, so we could determine if it was our cane.

• Brand Name: LARGE BASE QUAD CANE
• Type of Device: QUAD 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: 15823820
• MDR Text Key: 307692048
• Report Number: 3005739540-2022-00002
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2022

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: W1302BL
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 113 KG