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

Model Number	10381BLK-1
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2438477-2023-00014
• Device Sequence Number: 5660232
• Product Code: IPS
• UDI-Device Identifier: 00822383224916
• UDI-Public: 822383224916
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2023
• Report Date (Section F): 02/17/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10381BLK-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/07/2023
• Date Report to Manufacturer: 02/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Date Report Sent to FDA: 02/17/2023