MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD DRIVE; ROLLATOR

Model Number	10215BL-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a bariatric rollator.We have not been able to retrieve the device for evaluation.The end-user was sitting on the device on his patio.The front fork reportedly gave way.He slid out of the device and fell hitting his head.The device was stored outside or in the trunk of the car.Device weight cap is 500lbs.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL EQUIPMENT CO.,LTD; no. 589 hualu road,; huashi town; jiangyin city, jiangsu 21442 1; CH 214421
• MDR Report Key: 10397475
• Report Number: 2438477-2020-00038
• Device Sequence Number: 19460098
• Product Code: ITJ
• UDI-Device Identifier: 00822383100647
• UDI-Public: 822383100647
• 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): 08/12/2020
• Report Date (Section F): 08/12/2020

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: 10215BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2020
• Device Age: 7 YR
• Event Location: Home
• Date Report to Manufacturer: 08/12/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 200
• Date Report Sent to FDA: 08/12/2020