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	09/25/2020
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.We have not ben able to retrieve the device for evaluation.User caught his finger in the folding mechanism.He received 8 stitches.
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.We have not ben able to retrieve the device for evaluation.User caught his finger in the folding mechanism.He received 8 stitches.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10715675
• Report Number: 2438477-2020-00051
• Device Sequence Number: 11544704
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 00822383233222
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020
• Report Date (Section F): 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: R726RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/25/2020
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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: Death; Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 95
• Date Report Sent to FDA: 10/21/2020