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

Model Number	Q6 EDGE
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Abrasion (1689)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The "date of event" has not been provided.The device has not been made available for evaluation at this time.Should the device or further information become available, a follow-up report wil then be issued.
Event or Problem Description
Consumer alleges that while using her unit the speed went from 1 to 4 causing her to run into a door.She then super glued her controller.Approximately 2 weeks later while in her unit, the unit allegedly had the same issue causing her to run into her desk and injuring her leg.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; exeter PA 18643
• MDR Report Key: 6607583
• Report Number: 2530130-2017-00069
• Device Sequence Number: 13509336
• Product Code: ITI
• UDI-Device Identifier: 00606509400244
• UDI-Public: (01)00606509400244
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 06/01/2017

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: Q6 EDGE
• 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: 05/30/2017
• Initial Report FDA Received Date: 06/02/2017
• 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