MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; WHEELCHAIR, POWERED

Model Number	Q6 EDGE Z
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Provider alleges the consumer was leaving a fast food restaurant.The consumer was in his power chair and was crossing a threshold.A ramp which was not solidly attached to the threshold was allegedly pushed away by the front wheels of the power chair, which then allegedly ducked down in the space between the threshold and the ramp.The power chair allegedly tilted in forward direction and the occupant slid down in forward direction.The positioning belt allegedly could not keep his weight, and broke at the clasp under the strain allegedly causing the occupant to tumble forward to the floor.
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.
Event or Problem Description
Provider alleges the consumer was leaving a fast-food restaurant.The consumer was in his power chair and was crossing a threshold.A ramp which was not solidly attached to the threshold was allegedly pushed away by the front wheels of the power chair, which then allegedly ducked down in the space between the threshold and the ramp.The power chair allegedly tilted in forward direction and the occupant slid down in forward direction.The positioning belt allegedly could not keep his weight, and broke at the clasp under the strain allegedly causing the occupant to tumble forward to the floor.
Additional Manufacturer Narrative
Ramp was not secured, user error.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea, PA 18642 ; 8008008586
• MDR Report Key: 20087364
• Report Number: 2530130-2024-00561
• Device Sequence Number: 18064385
• Product Code: ITI
• UDI-Device Identifier: 00606509200073
• UDI-Public: 00606509200073
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K143383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: Q6 EDGE Z
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male