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	Bone Fracture(s) (1870)
Date of Event	04/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient identifier and the date of incident have not been provided.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 consumer was driving chair in reverse when it surged forward hitting a table.
Additional Manufacturer Narrative
The "date of event" was updated.The original input devices (specialty controls) and seating system were not returned.Pride made a good faith effort to acquire the these controls through the provider without success.With this, the evaluator can not draw any conclusion with the limited components returned.
Event or Problem Description
Alleges consumer was driving chair in reverse when it surged forward hitting a table.

• 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: 6457704
• Report Number: 2530130-2017-00045
• Device Sequence Number: 875338
• Product Code: ITI
• UDI-Device Identifier: 00606509100014
• UDI-Public: (01)00606509100014
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement 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