MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR

Model Number	JAZZY PASSPORT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Head Injury (1879)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been made available for evaluation.Should the device become available, or further information be provided, a follow-up report will then be issued.
Event or Problem Description
Alleges flipping device backwards on two different occasions.Alleges not operating on a steep ramp or anything out of the ordinary.
Event or Problem Description
Alleges flipping device backwards on two different occasions.Alleges not operating on a steep ramp or anything out of the ordinary.
Additional Manufacturer Narrative
The device was returned for evaluation.The alleged incident could not be duplicated.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• MDR Report Key: 11760892
• Report Number: 2530130-2021-00037
• Device Sequence Number: 17268932
• Product Code: ITI
• UDI-Device Identifier: 00606509100212
• UDI-Public: 00606509100212
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 10/12/2021

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: JAZZY PASSPORT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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: Hospitalization