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

Model Number RTL10365-ADJ

Device Problem Fracture (1260)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 10/01/2019

Event Type  Injury  

Event 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
• Type of Device: CANE
• Manufacturer (Section D): HOMECARE ENTERPRISE CO., LTD.; no. 488, lunmei road; changhua city; changhua,, 50071 ; TW 50071
• MDR Report Key: 9884725
• MDR Text Key: 191593360
• Report Number: 2438477-2020-00019
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00822383246123
• UDI-Public: 822383246123
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: RTL10365-ADJ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2020
• Distributor Facility Aware Date: 03/10/2020
• Device Age: 32 MO
• Event Location: Other
• Date Report to Manufacturer: 03/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 64