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

Model Number JAZZY SELECT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 12/16/2022

Event Type  Injury  

Event Description

Consumer alleges when she went to put the footplate down, it's allegedly so heavy that is scrapped her leg.

Manufacturer Narrative

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

Event Description

Consumer alleges when she went to put the footplate down, it's allegedly so heavy that is scrapped her leg.

Manufacturer Narrative

Per tech; unit is working properly, suggested replacing foot plates with elevated leg rests.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: WHEELCHAIR, POWERED
• 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 ; n/a; n/a; n/a, PA 18642 ; 8008008586
• MDR Report Key: 16148082
• MDR Text Key: 307194053
• Report Number: 2530130-2023-00004
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509100120
• UDI-Public: 00606509100120
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001970
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY SELECT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female