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

Model Number	JAZZY 600ES
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been 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
Consumer alleges that while riding on a bus in her chair, the driver made a sharp turn causing the consumer to allegedly fall out of the chair.
Additional Manufacturer Narrative
The alleged incident was not caused by the device.The provider evaluated and serviced the device in the field after the alleged incident.The provider replaced the batteries and the right motor.The device is working properly.
Event or Problem Description
Consumer alleges that while riding on a bus in her chair, the driver made a sharp turn causing the consumer to allegedly fall out of the chair.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; n/a; duryea PA 18642
• MDR Report Key: 6873869
• Report Number: 2530130-2017-00124
• Device Sequence Number: 718741
• Product Code: ITI
• UDI-Device Identifier: 00606509100038
• UDI-Public: 00606509100038
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/24/2018

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 600ES
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization