MAUDE Adverse Event Report: SUNRISE MEDICAL PRIVADA MISIONES QUICKIE IRIS; MANUAL WHEELCHAIR

Model Number EIZ4-2

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

Patient Problems Laceration(s) (1946); Injury (2348); Fracture, Arm (2351)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

This mdr is to report the injuries sustained to the end user in the car accident.No allegations of malfunction or defect were made by the dealer against the subject wheelchair.The dealer did mention that aside from the injuries to his son, the chair was also damaged in the car accident, with a bent frame and a tilt feature that is out of place.The dealer is working on getting a new chair for his son.No further investigation will be performed by sunrise medical.

Event Description

Per (b)(6) (dealer) the end user was in a car accident while sitting in his chair.(b)(6) states that transit brackets were used for the chair.The end user is the dealer's son.(b)(6) states his son was injured in the car accident and was taken to the doctor last week (date not provided).(b)(6) reported that his son sustained injuries to the orbital bone on his face, a laceration across the left eye, a right broken humerus and his left arm and wrist are also broken.

• Brand Name: QUICKIE IRIS
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 parque industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 7542921
• MDR Text Key: 109227772
• Report Number: 9616084-2018-00005
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 05022408048953
• UDI-Public: 05022408048953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIZ4-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention