MAUDE Adverse Event Report: HOMECARE ENTERPRISE CO., LTD. DRIVE; CANE

Model Number	RTL10365-ADJ
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a cane.Pms associate is awaiting return of the device for evaluation and phone interview with consumer for more information.We are filing this report in an overabundance of caution because she hit her head.End-user was at the bank waiting on line sitting on the cane seat when it broke.She fell on her tailbone and hit her head on a big long table.She went to the emergency room and took x rays of her head and tailbone.She had no breaks but large bruise that were painful.

• Brand Name: DRIVE
• Common Device Name: CANE
• Manufacturer (Section D): HOMECARE ENTERPRISE CO., LTD.; no. 488, lunmei road; changhua city; changhua,, 50071 ; TW 50071
• MDR Report Key: 9884725
• Report Number: 2438477-2020-00019
• Device Sequence Number: 19518158
• Product Code: IPS
• UDI-Device Identifier: 00822383246123
• UDI-Public: 822383246123
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2020
• Report Date (Section F): 03/26/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10365-ADJ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/10/2020
• Device Age: 32 MO
• Event Location: Other
• Date Report to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2020
• 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: Other
• Patient Age: 69 YR
• Patient Weight: 64
• Date Report Sent to FDA: 03/26/2020