MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVEMEDICAL QUAD CANE TIP; TIPS AND PADS, CANE, CRUTCH AND WALKER

Model Number	RTL10353
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hip Fracture (2349)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a cane tip by the provider, who stated that during use on a hardwood floor of their home, the end user fell and broke her hip, requiring hospitalization.The provider reported that the bottom of the cane tip does not grip to the hard floor surface during use.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.
Additional Manufacturer Narrative
The quad cane tip was returned to drive devilbiss healthcare for evaluation.The product was in good condition in its original packaging.The cane tip was reviewed on a hardwood floor confirming that there is grip when load is applied.No defects were found.Complaints data was reviewed for further insight on the cane tip design customer concern of the cane tip not gripping the floor surface.This complaint was the only one identified in a two-year time period.The supplier was notified of the complaint.This appears to be an isolated incident from the complaints data review.Complaints will continue to be monitored for trends.

• Brand Name: DRIVEMEDICAL QUAD CANE TIP
• Common Device Name: TIPS AND PADS, CANE, CRUTCH AND WALKER
• Manufacturer (Section D): COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 22804336
• Report Number: 2438477-2025-00038
• Device Sequence Number: 18354361
• Product Code: INP
• UDI-Device Identifier: 00822383545059
• UDI-Public: (01)00822383545059
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025
• Report Date (Section F): 11/21/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10353
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/08/2025
• Event Location: Home
• Date Report to Manufacturer: 11/21/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 11/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/21/2025