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	Injury (2348)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been made available for evaluation at this time.Should the device or further information become available, a follow-up report will then be issued.
Event or Problem Description
Provider alleges the consumer's seat came loose at the base where the bolts fasten to the frame allegedly causing the consumer to fall out.
Additional Manufacturer Narrative
The seat was returned and evaluated.Both the front and rear extrusion were secured.There was no evidence they came loose.
Event or Problem Description
Provider alleges the consumer's seat came loose at the base where the bolts fasten to the frame allegedly causing the consumer to fall out.

• 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: 8280729
• Report Number: 2530130-2019-00002
• Device Sequence Number: 1911455
• Product Code: ITI
• UDI-Device Identifier: 00606509100113
• UDI-Public: 00606509100113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/01/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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