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

Model Number JAZZY ELITE HD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bruise/Contusion (1754)

Event Date 02/21/2024

Event Type  Injury  

Event Description

Client alleges that he was trying to transfer into the chair and the chair moved causing him to fall.The chair then rolled back and ran over his hand.He allegedly hit his car and it allegedly hit his prosthetic leg breaking off a panel.

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.

Manufacturer Narrative

Alleged condition could not be duplicated.

Event Description

Client alleges that he was trying to transfer into the chair and the chair moved causing him to fall.The chair then rolled back and ran over his hand.He allegedly hit his car and it allegedly hit his prosthetic leg breaking off a panel.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea 18342 ; 8008008586
• MDR Report Key: 18807680
• MDR Text Key: 336563560
• Report Number: 2530130-2024-00338
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509100113
• UDI-Public: 00606509100113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY ELITE HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2020
• 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