• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRIVE MEDICAL WHEELCHAIR, MECHANICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DRIVE MEDICAL WHEELCHAIR, MECHANICAL Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDRIVE MEDICAL
Type of DeviceWHEELCHAIR, MECHANICAL
MDR Report Key6021760
MDR Text Key57160457
Report Number2438477-2016-00050
Device Sequence Number1
Product Code IOR
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received10/12/2016
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 FDA10/12/2016
Distributor Facility Aware Date09/12/2016
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/12/2016 Patient Sequence Number: 1
-
-