MAUDE Adverse Event Report: COMBO ZHONGSHAN MEDICAL EQUIPMENT DRIVE; ROLLATOR

Model Number	10257RD-1
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	02/01/2021
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 device has not been retrieved for evaluation.We will file a follow-up when additional data becomes available.The brakes did not engage fully.The user sat down and the device rolled.She fell and broke her clavicle bone and received some bruises on her hip.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): COMBO ZHONGSHAN MEDICAL EQUIPMENT; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong, 52841 4; CH 528414
• MDR Report Key: 12424407
• Report Number: 2438477-2021-00040
• Device Sequence Number: 3332700
• Product Code: ITJ
• UDI-Device Identifier: 00822383260204
• UDI-Public: 822383260204
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2021
• Report Date (Section F): 09/03/2021

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: 10257RD-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/23/2021
• Device Age: 4 YR
• Date Report to Manufacturer: 09/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2021
• 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: 47
• Date Report Sent to FDA: 09/03/2021