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

Model Number 731-852

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 316882326
• Report Number: 2438477-2023-00061
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00754021210237
• UDI-Public: 754021210237
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 731-852
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2023
• Distributor Facility Aware Date: 05/10/2023
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 06/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 91 KG