MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE S-646 SE

Model Number	S626/S646
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2026, the manufacturer was notified by a 72-year-old female power wheelchair user (approx.5'2", 260 lbs) requesting replacement parts, including drive wheels, batteries, and a left elevating leg rest (elr) footrest.The user reported that multiple authorized service providers declined to perform repairs, stating the wheelchair is old, requires extensive additional parts beyond those requested, is deteriorating, and is no longer serviceable.The service providers also indicated that certain replacement parts are no longer available due to product age.The user reported that in (b)(6) 2023, while exiting a bus via a ramp, the bus driver allegedly pushed the wheelchair from behind.The user stated she unintentionally contacted the joystick, causing the wheelchair to descend the ramp at speed and collide with a bush.The user reported the left footrest was broken and the seat back would no longer remain upright following the incident.The user stated she sustained a left leg and ankle injury described as a nerve injury.She reported no fractures or visible bruising and indicated she continues to seek medical care for the reported nerve-related symptoms.The user reported a pending legal claim related to the bus incident.At the time of complaint intake, the wheelchair remains in the user's possession at her home.Conclusion: in conclusion, there is no evidence of malfunction or defect from the wheelchair.Due to the injury that occured while using the medical device and required medical intervention, this mdr is being filed.
Event or Problem Description
On (b)(6) 2026, the manufacturer was notified by a 72-year-old female power wheelchair user (approx.5'2", 260 lbs) requesting replacement parts, including drive wheels, batteries, and a left elevating leg rest (elr) footrest.The user reported that multiple authorized service providers declined to perform repairs, stating the wheelchair is old, requires extensive additional parts beyond those requested, is deteriorating, and is no longer serviceable.The service providers also indicated that certain replacement parts are no longer available due to product age.The user reported that in (b)(6) 2023, while exiting a bus via a ramp, the bus driver allegedly pushed the wheelchair from behind.The user stated she unintentionally contacted the joystick, causing the wheelchair to descend the ramp at speed and collide with a bush.The user reported the left footrest was broken and the seat back would no longer remain upright following the incident.The user stated she sustained a left leg and ankle injury described as a nerve injury.She reported no fractures or visible bruising and indicated she continues to seek medical care for the reported nerve-related symptoms.The user reported a pending legal claim related to the bus incident with the bus driver.

• Brand Name: QUICKIE S-646 SE
• Common Device Name: QUICKIE S-646 SE
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 12002 volunteer blvd; mt. juliet TN 37122
• Manufacturer Contact: neeraj patel ; 12002 volunteer blvd; mt. juliet, TN 37122 ; 8003334000
• MDR Report Key: 24473936
• Report Number: 3019677893-2026-00002
• Device Sequence Number: 10277639
• Product Code: ITI
• UDI-Device Identifier: 00016958044256
• UDI-Public: 00016958044256
• Combination Product (Y/N): N
• 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): 02/04/2026

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: S626/S646
• Device Catalogue Number: EIS62
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 118 KG