MAUDE Adverse Event Report: CHANG CHENG FA DRIVE; ROLLATOR

Model Number	GV974BK-T
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Fracture, Arm (2351)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.The patient still has the unit.It is not available currently for evaluation.We nave photos on file.The enduser was coming around the rollator from back to front to sit down.He attempted to sit and the device and it collapsed and the front wheel fell off.The consumer fell hitting his elbow and head.He was taken to the hospital where he was diagnosed with a fractured elbow.He has a cast.Patient is being treated by an orthopaedist and receiving pain meds.He is in a cast.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): CHANG CHENG FA; no. 1 been ting; been-tsuoh village; chia-yi shiann, ; TW
• MDR Report Key: 8827205
• Report Number: 2438477-2019-00043
• Device Sequence Number: 2687828
• Product Code: ITJ
• UDI-Device Identifier: 00822383582221
• UDI-Public: 822383582221
• 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): 07/25/2019
• Report Date (Section F): 07/25/2019

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: GV974BK-T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2019
• Device Age: 3 MO
• Date Report to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2019
• 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: Hospitalization
• Patient Weight: 104
• Date Report Sent to FDA: 07/25/2019