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 Code	Abrasion (1689)
Date of Event	11/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been made available for evaluation at this time.Should further information or the device become available, a follow-up report will then be submitted.
Event or Problem Description
Alleges the turn speed caused consumer to run into a wall.Alleges motioning to turn the chair off but apparently caught his sleeve on or brushed against the joystick with his wrist.The chair accelerated quickly pinning his legs against dresser and cut his leg.
Additional Manufacturer Narrative
The device was evaluated in the field by a pride representative.The device was reprogrammed for acceleration and turning speed to better suit to user's needs and capabilities.The unit is working properly.
Event or Problem Description
Alleges the turn speed caused consumer to run into a wall.Alleges motioning to turn the chair off but apparently caught his sleeve on or brushed against the joystick with his wrist.The chair accelerated quickly pinning his legs against dresser and cut his leg.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; n/a; exeter PA 18643
• MDR Report Key: 7013029
• Report Number: 2530130-2017-00146
• Device Sequence Number: 13482296
• Product Code: ITI
• UDI-Device Identifier: 00606509100137
• UDI-Public: 00606509100137
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2017
• Supplement Date Received by Manufacturer: 11/05/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 12/04/2017
• 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