MAUDE Adverse Event Report: DRIVE; LAP BELT

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

Patient Problem Death (1802)

Event Date 08/08/2008

Event Type  Death  

Event Description

(b)(4) received notification from defendant's attorney of an incident involving a lap belt that (b)(4) imports and distributes.The patient was a passenger in an ambulette when a collision or near collision led to an abrupt stop, allegedly causing serious injury.The patient was sitting in a wheelchair (different brand) but using a drive lap belt at the time of the incident.A few weeks later, the patient died, allegedly due to the injuries suffered from the motor vehicle accident.The lap belt was not returned for evaluation, therefore, we are unable to identify the manufacturer.

• Brand Name: DRIVE
• Type of Device: LAP BELT
• MDR Report Key: 6075398
• MDR Text Key: 59040784
• Report Number: 2438477-2016-00056
• Device Sequence Number: 1
• Product Code: IQB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/03/2016,10/07/2016

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2016
• Distributor Facility Aware Date: 10/07/2016
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization