MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	R728RD
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.Notification of the event was executed though a third party claims administrator of the service provider.Pms is attempting to retrieve the device for evaluation.The end-user was walking down a ramp at a rest stop when the walker reportedly broke and she fell.She was diagnosed and treated for a fractured femur.She was sent to rehab.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 7713488
• Report Number: 2438477-2018-00037
• Device Sequence Number: 19109438
• Product Code: ITJ
• UDI-Device Identifier: 00822383233253
• UDI-Public: 822383233253
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/24/2018
• Report Date (Section F): 07/24/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: R728RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2018
• 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
• Date Report Sent to FDA: 07/24/2018