MAUDE Adverse Event Report: COM-DA HEALTHCARE DRIVE; WALKER

Model Number 10240-1

Device Problem Material Fragmentation (1261)

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

Event Date 09/11/2018

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a walker.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The device was not returned for evaluation.The device snapped while in use and he fell hitting his back and head.An ambulance was called.No further information is available.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): COM-DA HEALTHCARE; unit 3 no.94 dongcheng road; dong sheng town; zhong shan city, guangdon ; CH
• MDR Report Key: 11072172
• MDR Text Key: 223606711
• Report Number: 2438477-2018-00094
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383119427
• UDI-Public: 822383119427
• 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: 12/29/2020,12/24/2020

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: 10240-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/07/2018
• Device Age: 6 MO
• Date Report to Manufacturer: 12/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1