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

Model Number	JAZZY SELECT 6
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Sprain (2083); Neck Pain (2433)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact "date of event" was not been provided.Alleges incident occurred in (b)(6) 2019.The device has not yet been evaluated.Should further information become available, a follow-up report will then be issued.
Event or Problem Description
Consumer alleges while she was on a bus her chair allegedly tipped over and she hit her head on the window.
Additional Manufacturer Narrative
The consumer was sitting in the device while on a bus.Please note that this unit is not rated for occupied transit.A field service technician (fst) evaluated and adjusted device.The device is working properly.
Event or Problem Description
Consumer alleges while she was on a bus her chair allegedly tipped over and she hit her head on the window.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 9482339
• Report Number: 2530130-2019-00140
• Device Sequence Number: 4129693
• Product Code: ITI
• UDI-Device Identifier: 00606509100137
• UDI-Public: 00606509100137
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: JAZZY SELECT 6
• 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: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization