MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT DRIVE; ROLLATOR

Model Number R726BK

Device Problem Solder Joint Fracture (2324)

Patient Problem Fall (1848)

Event Date 05/24/2018

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 using the device in the restroom when the frame above the wheel snapped.He fell and hit his head.He went to the hospital.He did not sustain serious injuries.The unit was returned.Evaluation showed moderate usage.The unit has residue on the seat and tube framing.It was delivered with missing parts, such as height adjustment screws.The left brake was slightly loose but would be conforming if adjusted.Although the right wheel is detached with the frame tube, the brake is still conforming.The frame break of the tubing happened at the screw that connected the rollator frame to the folding hinge.This may have been due to stress over time.The unit is defective.Historical complaints data of the same nature was reviewed and found limited with no trend.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang lianhu industrial park; danyang city,, jiangsu
• MDR Report Key: 10121589
• MDR Text Key: 194812939
• Report Number: 2438477-2018-00067
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383245997
• UDI-Public: 822383245997
• 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: 06/04/2020

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: No Information
• Device Model Number: R726BK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2020
• Distributor Facility Aware Date: 05/25/2018
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 06/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization