MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM715; POWERED WHEELCHAIR

Model Number	EIPW11
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) provided the client's phone number to sunrise medical's inside sales representative, (b)(4).(b)(4) called the end user for additional information.The end user was asked how the incident occurred.She stated that she was down in the laundry room and when she tried to press the swing away leg rest release button it didn't release.She then tried using her leg to push the leg rests away and that is when the cleaning lady noticed she was bleeding.The end user stated she received a 9" long cut and required 12 stitches.She said she is doing fine now.She stated that the difficulty of releasing the swing away leg rest was not a malfunction but her basic inability to reach the release lever and that is why she used her leg.She did contact the dealer and requested a quote to replace the swing away style leg rests for the center mount single leg rest, as the swing away is simply not working out for her.This mdr filing is to report the injury sustained; however, it was not due to a malfunction or defect in the product as there were also no allegations of malfunction or defect made against the subject wheelchair by the end user.No further investigation will be performed by sunrise medical at this time.
Event or Problem Description
Dealer (b)(4) reported the front power elrs (elevating leg rests) allegedly cut the end user's leg that required 12 stitches.The end user allegedly has severe swelling "edema" which is a pre-existing condition.

• Brand Name: QUICKIE QM715
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 8236664
• Report Number: 2937137-2019-00001
• Device Sequence Number: 1929173
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/11/2018

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: EIPW11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/10/2019
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 174