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

Model Number	795B
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hip Fracture (2349)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.Drive's pms team has not received the device for evaluation.When/if the device is received and evaluated a follow-up report will be filed.The end-user was shopping while using the device.She was seated and bent over to put something in the basket and the rollator flipped.911 was called and she went to the er.X-rays were taken and she was sent home with a leg brace.The diagnosis was a bruised knee & pulled muscle.She followed up with aa physician days later for more x-rays.She went back to er several days later and they found that her meniscus was damaged along with a small fracture in left hip and a pulled hamstring.She stayed at the hospital for several days before being transferred to rehab for several weeks.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.; 3 shenghui south road; nantou town,; zhongshan city, ; CH
• MDR Report Key: 8956214
• Report Number: 2438477-2019-00061
• Device Sequence Number: 11415517
• Product Code: ITJ
• UDI-Device Identifier: 00822383213484
• UDI-Public: 822383213484
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/03/2019
• Report Date (Section F): 09/03/2019

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: 795B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2019
• Device Age: 46 MO
• Event Location: Other
• Date Report to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2019
• 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: 57
• Date Report Sent to FDA: 09/03/2019