PRIDE MOBILITY PRODUCTS I-DRIVE N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-09 for PRIDE MOBILITY PRODUCTS I-DRIVE N/A manufactured by Pride Mobility Products.

MAUDE Entry Details

• Report Number: 2530130-2019-00114
• MDR Report Key: 9171645
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-10-09
• Date of Report: 2019-10-03
• Date Mfgr Received: 2019-09-23
• Date Added to Maude: 2019-10-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MISS KELLY LIVINGSTON
• Manufacturer Street: 401 YORK AVE N/A
• Manufacturer City: DURYEA PA 18642
• Manufacturer Country: US
• Manufacturer Postal: 18642
• Manufacturer Phone: 5706555574
• Manufacturer G1: N/A
• Manufacturer Street: N/A N/A
• Manufacturer City: N/A
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PRIDE MOBILITY PRODUCTS
• Generic Name: WHEELCHAIR COMPONENT
• Product Code: KNN
• Date Received: 2019-10-09
• Model Number: I-DRIVE
• Catalog Number: N/A
• Lot Number: N/A
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PRIDE MOBILITY PRODUCTS
• Manufacturer Address: 401 YORK AVE N/A DURYEA PA 18642 US 18642

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2019-10-09