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

Model Number	GV974RD-T
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device whihc is a rollator.Our pms team was advised of this event by an attorney's letter.We do not have possession of the device nor do we expect to in the near future.We are filing this report in an overabundance of caution.The enuder reportedly suffered an injury on (b)(6) 2019 while using the device.The supporting leg for a front wheel sheared off the product causing her to fall forward, fracturing her wrist.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): CHANG CHENG FA ENTERPRISE CO., LIMITED; no. 1 been ting, been-tsuoh vi; chia-yi shiann; shi-koou shiang chiayi distri, ; TW
• MDR Report Key: 8912129
• Report Number: 2438477-2019-00052
• Device Sequence Number: 18986872
• Product Code: ITJ
• UDI-Device Identifier: 00822383582238
• UDI-Public: 822383582238
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/20/2019
• Report Date (Section F): 08/20/2019

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: GV974RD-T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2019
• Device Age: 3 YR
• Date Report to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2019
• 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
• Date Report Sent to FDA: 08/20/2019