MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q500M/Q400M SERIES

Model Number	Q500M-Q400M SERIES
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Background information: q500m/q400m owner's manual, page 17 states: "the safety of the user during transportation depends upon the diligence of the person securing the tie down restraints, and they should have received appropriate instructions and/or training in their use." r-net control system owner's manual, page 11 states: in the event of the wheelchair moving in an unexpected way release the joystick.This action will stop the wheelchair under any circumstances.Discussion: evaluating the complaint, it was reported the due to unexpected acceleration by the wheelchair the user got injured.No further information was shared by the user.There was no evidence provided that the wheelchair malfunctioned.Conclusion: in conclusion, due to the allegation of a serious injury, this mdr is being filed.
Event or Problem Description
Per (b)(6), user is (b)(6), claiming injury due to unexpected acceleration by the wheelchair.Documents have been forwarded.User is (b)(6), born 1954.(b)(6).

• Brand Name: QUICKIE Q500M/Q400M SERIES
• Common Device Name: Q500M/Q400M SERIES
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 12002 volunteer blvd; mount juliet TN 37122
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 12002 volunteer blvd; mount juliet TN 37122
• Manufacturer Contact: neeraj patel ; 12002 volunteer blvd; mount juliet, TN 37122 ; 8003334000
• MDR Report Key: 24974215
• Report Number: 3019677-2026-00008
• Device Sequence Number: 10455740
• Product Code: ITI
• UDI-Device Identifier: 00016958060485
• UDI-Public: (01)00016958060485
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: Q500M-Q400M SERIES
• Device Catalogue Number: EIPW30
• Device Lot Number: 15794401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female