MAUDE Adverse Event Report: DRIVE MEDICAL CANADA, INC. DRIVE MEDICAL DESIGN; WHEELCHAIR

Device Problems Mechanical Problem (1384); Unintended System Motion (1430)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/28/2017

Event Type  Injury  

Event Description

Patient said that his brakes on his wheelchair did not stop the wheelchair from rolling and slid out of the wheelchair to ground.Patient assessed, pain olio, soreness on coccyx, no pain medication taken or needed.

• Brand Name: DRIVE MEDICAL DESIGN
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): DRIVE MEDICAL CANADA, INC.
• MDR Report Key: 6787580
• MDR Text Key: 82588776
• Report Number: MW5071509
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 99 YR