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

Model Number	JAZZY ELITE HD
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact "date of event" was not provided.The device has not yet been made available for evaluation.Should further information or the device become available for evaluation, a follow-up report will then be issued.
Event or Problem Description
Alleges going down little incline and it tipped over and fell injuring consumer.Alleges unit doesn't have front caster wheels and this is why consumer fell.
Additional Manufacturer Narrative
A field service technician evaluated the device.Fst tested the motors and batteries.Unit is working properly.
Event or Problem Description
Alleges going down little incline and it tipped over and fell injuring consumer.Alleges unit doesn't have front caster wheels and this is why consumer fell.

• 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: 8557201
• Report Number: 2530130-2019-00050
• Device Sequence Number: 2260523
• Product Code: ITI
• UDI-Device Identifier: 00606509100113
• UDI-Public: 00606509100113
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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 ELITE HD
• 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: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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