MAUDE Adverse Event Report: UNKNOWN DRIVE; WHEELCHAIR

Model Number	BLS16FBD-ELR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a wheelchair.The device was not involved in the incident.The packaging was involved in the incident.The enduser cut her hand on the packaging of the device.She was hospitalized and required stitches.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9126464
• Report Number: 2438477-2019-00065
• Device Sequence Number: 2820066
• Product Code: IOR
• UDI-Device Identifier: 00822383293950
• UDI-Public: 822383293950
• Combination Product (Y/N): N
• 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): 09/26/2019
• Report Date (Section F): 09/26/2019

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: No Information
• Device Model Number: BLS16FBD-ELR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2019
• 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
• Date Report Sent to FDA: 09/26/2019