MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number 102EXL-RD

Device Problem Solder Joint Fracture (2324)

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

Event Type  Injury  

Event Description

Drive devilbiss is the initial importer of the device which is a rollator.This report is being tendered in an overabundance of caution in response to an mdr regression analysis.End user was walking to the garage when the wheel broke off at the weld.He fell and hit his head.He went to the hospital and was diagnosed with a concussion.He unit was returned and evaluated.The conclusion of the evaluation was that the 102exl-rd returned on rma (b)(4) showed signs of moderate usage.Both the left and right rear brakes were conforming.The front left wheel was delivered detached from the unit.When inspected, the front left hardware was still intact, showing no nonconformities.The front left fork, however, had a clean break in the molding.This may have been due to improper molding of the front fork.Unit is defective.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10177220
• MDR Text Key: 196105517
• Report Number: 2438477-2018-00072
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 08223833560014
• UDI-Public: 8223833560014
• 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: 06/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102EXL-RD
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2020
• Distributor Facility Aware Date: 06/13/2018
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 64