MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM710; POWERED WHEELCHAIR

Model Number	EIPW11
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dealer (b)(6) stated the left side footplate and caster arm were damaged.He also stated that in the past, this user has had similar damage to the same side caster arm and fork.However, was not clear if it was due to a similar type of incident.The dealer stated the end user didn't consider this a serious injury and did not want to have it noted.The end user is only looking to replace parts at this point.There was no allegation of malfunction or defect made against the wheelchair.This mdr filing is to report the injury only.Sunrise medical considers this occurrence accidental and no further investigation will be performed at this time.
Event or Problem Description
Per dealer, (b)(6), the end user was recently hit by a car while crossing at a cross walk.He did receive stitches due to an injury to his foot.

• Brand Name: QUICKIE QM710
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 8899489
• Report Number: 2937137-2019-00022
• Device Sequence Number: 16701789
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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: EIPW11
• Device Catalogue Number: EIPW11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/15/2019
• 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