MAUDE Adverse Event Report: CHANG CHENG FA ENTERPRISE CO., LIMITED DRIVE; ROLLATOR

Model Number	RTL10266BK
Medical Device Problem Codes	Fracture (1260); Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.The unit has not been returned for evaluation.The seat broker while crossing the street.The user hit his head and received medical attention and therapy.Device is not meant to be a transport device.Hangtag notes "do not move rollator while seated.The brakes must remain locked" while seated.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): CHANG CHENG FA ENTERPRISE CO., LIMITED; 1 been ting, been-tsuoh vilage; chia-yi shiann; shi-koou shiang chiayi - distr, ; TW
• MDR Report Key: 9673022
• Report Number: 2438477-2020-00008
• Device Sequence Number: 380234
• Product Code: ITJ
• UDI-Device Identifier: 00822383505305
• UDI-Public: 822383505305
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2020
• Report Date (Section F): 02/05/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: RTL10266BK
• Device Catalogue Number: RTL10266BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/03/2020
• Device Age: 40 MO
• Event Location: Other
• Date Report to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 84 YR
• Patient Weight: 88
• Date Report Sent to FDA: 02/05/2020