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

Model Number	J6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.
Event or Problem Description
Provider alleges consumer was reaching for something and her chair allegedly drove off of the sidewalk causing the consumer to allegedly break both legs.Caregiver alleges unit drives on its own.
Additional Manufacturer Narrative
The device was returned and evaluated.The alleged condition (inadvertent movement) could not be duplicated.
Event or Problem Description
Provider alleges consumer was reaching for something and her chair allegedly drove off of the sidewalk causing the consumer to allegedly break both legs.Caregiver alleges unit drives on its own.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 7697836
• Report Number: 2530130-2018-00089
• Device Sequence Number: 13733196
• Product Code: ITI
• UDI-Device Identifier: 00606509100014
• UDI-Public: 00606509100014
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: J6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization