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

Device Problems Component Missing (2306); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Dealer is stating that the right side back mounting bracket is bent and the hardware is missing.This is on a pride mobility chair, and the patient is in a facility.Dealer said the patient leans to the right a lot, he states the facility has no idea where the hardware went.Dealer had no model of the back, only thing he could provide was (b)(4) which is possibly a motion concepts model number.No other information provided.Invacare (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: WHEELCHAIR, POWERED
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS CORP
• MDR Report Key: 17536288
• MDR Text Key: 321469821
• Report Number: MW5143178
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1