MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QS5X; MECHANICAL WHEELCHAIR

Model Number	QUICKIE QS5X
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Rash (2033)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Discussion: in evaluating the complaint, the end user reported that, on (b)(6) 2025 was in a vehicular accident.Per the end user, was crossing a cross walk and was hit by a car; pinned underneath the chair and received road rash.There was no evidence provided that the wheelchair malfunctioned.There was no information provided on what specific injuries the end user sustained or what treatment options were necessary.Conclusion: in conclusion, there is no evidence of malfunction from the wheelchair.Due to the allegation of potential serious injuries that required hospitalization, this mdr is being filed.
Event or Problem Description
End user reported that was crossing a cross walk on (b)(6) 2025 and was hit by a car; pinned underneath the chair and received road rash.

• Brand Name: QUICKIE QS5X
• Common Device Name: MECHANICAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 12002 volunteer blvd; mount juliet TN 37122
• Manufacturer (Section G): SUNRISE MEDICAL TECNOLOGIAS, S.A. DE CV; 22260 sin calle; el realito; tijuana, baja california 22250 ; MX 22250
• Manufacturer Contact: neeraj patel ; 12002 volunteer blvd; mount juliet, TN 37122 ; 8035717205
• MDR Report Key: 25640483
• Report Number: 9616084-2026-00001
• Device Sequence Number: 13181705
• Product Code: IOR
• UDI-Device Identifier: 00016958059526
• UDI-Public: (01)00016958059526
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K123975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: QUICKIE QS5X
• Device Catalogue Number: EIF7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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: Unknown