MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	R726RD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.End-user cut leg on the hinge screw of the device.She received a gash on her right leg that required 14 stitches.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8584208
• Report Number: 2438477-2019-00022
• Device Sequence Number: 16953067
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 822383233222
• 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): 05/06/2019
• Report Date (Section F): 05/06/2019

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: R726RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/08/2019
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2019
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 91
• Date Report Sent to FDA: 05/06/2019