INVACARE MATRX PB BACK 16 W X 12 H 9153644848 MPB1612

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-02-19 for INVACARE MATRX PB BACK 16 W X 12 H 9153644848 MPB1612 manufactured by Invacare Cleveland Street.

Event Text Entries

[5493943] Dealer states that there are stress cracks around the back where the hardware attaches.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1219590-2015-00043
• MDR Report Key: 4526440
• Report Source: 08
• Date Received: 2015-02-19
• Date of Report: 2015-02-11
• Date Mfgr Received: 2015-02-11
• Date Added to Maude: 2015-03-24
• 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
• Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: KEVIN GUYTON
• Manufacturer Street: ONE INVACARE WAY
• Manufacturer City: ELYRIA OH 44036
• Manufacturer Country: US
• Manufacturer Postal: 44036
• Manufacturer Phone: 8003336900
• Manufacturer G1: INVACARE CLEVELAND STREET
• Manufacturer Street: 899 CLEVELAND STREET
• Manufacturer City: ELYRIA OH 44036
• Manufacturer Country: US
• Manufacturer Postal Code: 44036
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INVACARE MATRX PB BACK 16 W X 12 H 9153644848
• Generic Name: CUSHION, WHEELCHAIR
• Product Code: IMP
• Date Received: 2015-02-19
• Model Number: MPB1612
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INVACARE CLEVELAND STREET
• Manufacturer Address: 899 CLEVELAND STREET ELYRIA OH 44036 US 44036

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-02-19