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

Model Number Q6 EDGE

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

The device has not been made available for evaluation at this time.Should the device or further information become available, a follow-up report will be generated.

Event Description

Received information that a chair allegedly provided by reliable medical to a patient was involved in a fire resulting in the patient sustaining injuries.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york ave; duryea, PA 18642 ; 5706024056
• MDR Report Key: 7360972
• MDR Text Key: 103129960
• Report Number: 2530130-2018-00037
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization