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

Model Number	R44
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
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
Consumer's daughter alleges she went for a walk with her mother around her house and when they were going down a street the chair allegedly did not stop and allegedly began to roll downhill on its own.Consumer alleges her mother shouted that the chair did not stop.Consumer's daughter ran to try to stop it and she only managed to stop it a little but the chair went against the curb and consumer's mother allegedly fell off the chair.
Event or Problem Description
Consumer's daughter alleges she went for a walk with her mother around her house and when they were going down a street the chair allegedly did not stop and allegedly began to roll downhill on its own.Consumer alleges her mother shouted that the chair did not stop.Consumer's daughter ran to try to stop it and she only managed to stop it a little but the chair went against the curb and consumer's mother allegedly fell off the chair.
Additional Manufacturer Narrative
On (b)(6) 2024 tech went out to evaluate the unit.The unit functioned properly.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: 20310533
• Report Number: 2530130-2024-00592
• Device Sequence Number: 7726813
• Product Code: ITI
• UDI-Device Identifier: 00606509200134
• UDI-Public: 00606509200134
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K011993
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2021

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: R44
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2022
• 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: Female