MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; CANE

Model Number	731-852
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a cane by an end user, who stated that the "[cane] base is not large enough" and that she fell to the ground and sustained bruising to her hip while using it, but did not receive any medical treatment.The end user specifically stated that "there is nothing wrong with the cane except she does not feel the base is big enough." drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Common Device Name: CANE
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; no 1 jinzhao st, west district; no. 6 workshop ii; zhongshan city, guangdong ; CH
• MDR Report Key: 17088441
• Report Number: 2438477-2023-00061
• Device Sequence Number: 16870403
• Product Code: IPS
• UDI-Device Identifier: 00754021210237
• UDI-Public: 754021210237
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2023
• Report Date (Section F): 06/08/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 731-852
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/10/2023
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 06/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Date Report Sent to FDA: 06/08/2023