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

Model Number JAZZY SPORT 2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Hip Fracture (2349)

Event Type  Death  

Manufacturer Narrative

The exact "date of event" and exact "date of death" were not provided.The device has not yet been made available for evaluation.If the device or further information becomes available, a follow-up report will then be issued.

Event Description

Consumer's daughter in law alleges that the consumer went to stand up and allegedly fell.

Manufacturer Narrative

The device was returned and evaluated.The physical evidence appears to suggest the end user was using the armests for weight bearing purposes.

Event Description

Consumer's daughter in law alleges that the consumer went to stand up and allegedly fell.

• 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: 8180050
• MDR Text Key: 130872179
• Report Number: 2530130-2018-00180
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509100175
• UDI-Public: 00606509100175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY SPORT 2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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): Death; Hospitalization