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

Model Number JAZZY ELITE ES-1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Vertebral Fracture (4520)

Event Date 11/10/2018

Event Type  Death  

Manufacturer Narrative

The "serial #" has 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 issued.

Event Description

Alleges the customer fell from the wheelchair several times.Alleges suffering a head injury from the last fall.Customer passed away during an unrelated surgery.

Event Description

Alleges the customer fell from the wheelchair several times.Alleges suffering a head injury from the last fall.Customer passed away during an unrelated surgery.

Manufacturer Narrative

The "serial #", "unique identifier (udi)#", and "device manufacture date" have been updated.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 issued.

Event Description

Alleges the customer fell from the wheelchair several times.Alleges suffering a head injury from the last fall.Customer passed away during an unrelated surgery.

Manufacturer Narrative

The "model #" has been updated.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 issued.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 11003661
• MDR Text Key: 221299766
• Report Number: 2530130-2020-00115
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• PMA/PMN Number: K092961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2021

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: JAZZY ELITE ES-1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 12/08/2020; 12/08/2020
• Supplement Dates FDA Received: 01/11/2021; 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization