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

Model Number JAZZY AIR 2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bruise/Contusion (1754)

Event Date 01/29/2024

Event Type  Injury  

Event Description

Consumer alleges the speed on the unit is erratic.Consumer also alleges he hit a wall and got pinned under a desk while in his unit.

Manufacturer Narrative

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

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18643
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea 18344 ; 8008008586
• MDR Report Key: 18674708
• MDR Text Key: 334946379
• Report Number: 2530130-2023-00316
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY AIR 2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2023
• 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): Other
• Patient Sex: Male