MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.9 DRIVE; ROLLATOR

Model Number	795B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/14/2020
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 product will not be recovered for evaluation due to covid-19 protocols.Customer was sitting on the device and one of the front swivel wheels broke completely off where the fork fastener goes into the frame.Customer fell back and hit her head on porcelain tile.She believes she had a concussion.She did not go to the hospital due to covid-19 pandemic but contacted an online doctor.Product weight cap is (b)(6) lbs.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.9; 3 shenghui south road; nantou town; zhongshan city, guangdong ; CH
• MDR Report Key: 10012495
• Report Number: 2438477-2020-00023
• Device Sequence Number: 19355059
• Product Code: ITJ
• UDI-Device Identifier: 00822383213484
• UDI-Public: 822383213484
• 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): 04/29/2020
• Report Date (Section F): 04/29/2020

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: 795B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/14/2020
• Device Age: 16 MO
• Date Report to Manufacturer: 04/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 132
• Date Report Sent to FDA: 04/29/2020