MAUDE Adverse Event Report: CHANG CHENG FA DRIVE; ROLLATOR

Model Number	GV974RD-T
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.Pms is coordinating the return of the device and wheel for evaluation.End-user was walking with the device when the right wheel fell off.He fell and was injured.He reportedly injured his shoulder and neck.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): CHANG CHENG FA; 1 been ting been; been-tsuoh village; chia-yi shiann, shi-koou shiang chiayi ; TW
• MDR Report Key: 7945234
• Report Number: 2438477-2018-00049
• Device Sequence Number: 1514200
• Product Code: ITJ
• UDI-Device Identifier: 00822383582238
• UDI-Public: 822383582238
• Combination Product (Y/N): N
• 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): 10/01/2018
• Report Date (Section F): 10/01/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: GV974RD-T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/17/2018
• Event Location: Other
• Date Report to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2018
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 98
• Date Report Sent to FDA: 10/01/2018