MAUDE Adverse Event Report: DRIVE MEDICAL; WHEELCHAIR, MECHANICAL

Device Problems Inadequate or Insufficient Training (1643); Human Factors Issue (2948)

Patient Problem Injury (2348)

Event Date 04/27/2015

Event Type  Injury  

Event Description

(b)(4) received a summons through the mail regarding a incident, involving a wheelchair, a product imported and distributed by (b)(4).The claimant sustained injuries when the (b)(4) employees negligently failed to place a thoracolumbosacral orthosis (tlso brace) on the claimant before dignity health employees negligently operated his wheelchair improperly while being transported to (b)(4).This report is based on the information that was provided in the summons that was received.

• Brand Name: DRIVE MEDICAL
• Type of Device: WHEELCHAIR, MECHANICAL
• MDR Report Key: 6021760
• MDR Text Key: 57160457
• Report Number: 2438477-2016-00050
• Device Sequence Number: 1
• Product Code: IOR
• 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: 10/12/2016,09/12/2016

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: Lay User/Patient
• 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: 10/12/2016
• Distributor Facility Aware Date: 09/12/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other