MAUDE Adverse Event Report: FORT METAL PLASTIC CO., LTD DRIVE; QUAD CANE

Model Number RTL10310

Device Problem Fracture (1260)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 05/19/2021

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a cane.We have not received the device for evaluation.We are filing this report in an over abundance of caution.We will file a follow up when additional data becomes known.End-user reported that the cane broke in half causing him to fall down 3 stairs hitting his head and hurting back.We are awaiting confirmation of medical service.

• Brand Name: DRIVE
• Type of Device: QUAD CANE
• Manufacturer (Section D): FORT METAL PLASTIC CO., LTD; yi he civil affairs; industrial area; guongdong 51602 3; CH 516023
• MDR Report Key: 11917025
• MDR Text Key: 253732433
• Report Number: 2438477-2021-00020
• Device Sequence Number: 1
• Product Code: IPS
• UDI-Device Identifier: 00822383254050
• UDI-Public: 822383254050
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2021

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: RTL10310
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2021
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2021
• 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: 75 YR