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

Model Number Q6 EDGE 3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bruise/Contusion (1754); Sprain (2083); Tooth Fracture (2428)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

The device has not yet been made available for evaluation.Should the device or further information become available, a follow-up report will then be issued.

Event Description

Consumer alleges while driving at full speed his footplate hit a curb, allegedly causing the chair to come to a full stop, and the consumer allegedly flew out of the chair.

Manufacturer Narrative

A pride rep evaluated the chair and repaired the footplate.The rep also revised some settings to better suit the customer.Unit is working properly.

Event Description

Consumer alleges while driving at full speed his footplate hit a curb, allegedly causing the chair to come to a full stop, and the consumer allegedly flew out of the chair.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• MDR Report Key: 9794589
• MDR Text Key: 189441253
• Report Number: 2530130-2020-00031
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509200158
• UDI-Public: 00606509200158
• Combination Product (y/n): N
• PMA/PMN Number: K143383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE 3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization