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

Model Number HCANE-BL-C2

Device Problem Break (1069)

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 "bottom portion of the cane broke" and she fell.There was no report or evidence of illness, injury or medical treatment associated with the complaint.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• 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: 17088938
• MDR Text Key: 316882248
• Report Number: 2438477-2023-00060
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00822383571041
• UDI-Public: 822383571041
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HCANE-BL-C2
• 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
• Date Report to Manufacturer: 06/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female