PREMIUM MULTIFIRE TA 010315-

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-27 for PREMIUM MULTIFIRE TA 010315- manufactured by Covidien Lp Llc North Haven.

MAUDE Entry Details

• Report Number: 1219930-2019-03767
• MDR Report Key: 8741833
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-06-27
• Date of Report: 2019-09-03
• Date of Event: 2019-06-06
• Date Mfgr Received: 2019-08-12
• Date Added to Maude: 2019-06-27
• 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: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: LISA HERNANDEZ
• Manufacturer Street: 60 MIDDLETOWN AVE.
• Manufacturer City: NORTH HAVEN CT 06473
• Manufacturer Country: US
• Manufacturer Postal: 06473
• Manufacturer Phone: 2034925563
• Manufacturer G1: COVIDIEN LP LLC NORTH HAVEN
• Manufacturer Street: 195 MCDERMOTT RD
• Manufacturer City: NORTH HAVEN CT 06473
• Manufacturer Country: US
• Manufacturer Postal Code: 06473
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PREMIUM MULTIFIRE TA
• Generic Name: APPARATUS, SUTURING, STOMACH AND INTESTINAL
• Product Code: FHM
• Date Received: 2019-06-27
• Returned To Mfg: 2019-06-19
• Model Number: 010315-
• Catalog Number: 010315-
• Device Expiration Date: 1999-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN LP LLC NORTH HAVEN
• Manufacturer Address: 195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-27