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

Model Number 10381BLK-1

Device Problem Device Slipped (1584)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a cane by an end user, who stated that "while walking with the cane it got wet and he slipped and fell." the end user hit his head but did not seek medical attention.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 street, west di; no. 6 workshop ii; zhongshan city, guangdong 62348 ; CH 62348
• MDR Report Key: 16485683
• MDR Text Key: 310697411
• Report Number: 2438477-2023-00014
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00822383224916
• UDI-Public: 822383224916
• 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: 02/17/2023,03/06/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 10381BLK-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2023
• Distributor Facility Aware Date: 02/07/2023
• Date Report to Manufacturer: 02/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 84 KG