MAUDE Adverse Event Report: UNKNOWN DRIVE; WHEELCHAIR

Model Number BLS16FBD-ELR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 08/29/2019

Event Type  Injury  

Event 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
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9126464
• MDR Text Key: 162083014
• Report Number: 2438477-2019-00065
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383293950
• UDI-Public: 822383293950
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BLS16FBD-ELR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2019
• Distributor Facility Aware Date: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention