MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number 700-961

Device Problem Solder Joint Fracture (2324)

Patient Problem Fall (1848)

Event Date 09/25/2020

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device, which is a rollator.The device has not been recovered for evaluation.A follow-up report will be submitted, once there is additional information available.While in use the fork assembly detached from the frame.The user fell, and hit her head.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10906339
• MDR Text Key: 218587590
• Report Number: 2438477-2020-00060
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754021210893
• UDI-Public: 754021210893
• 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: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 700-961
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2020
• Distributor Facility Aware Date: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 91