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

Model Number	EIZ4-2
Health Effect - Clinical Codes	Laceration(s) (1946); Injury (2348); Fracture, Arm (2351)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 parque industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• MDR Report Key: 7542921
• Report Number: 9616084-2018-00005
• Device Sequence Number: 1200847
• Product Code: IOR
• UDI-Device Identifier: 05022408048953
• UDI-Public: 05022408048953
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K123975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: EIZ4-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention