PRESSURE MONITORING KIT T100209B

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 2020-02-14 for PRESSURE MONITORING KIT T100209B manufactured by Edwards Lifesciences Dr.

MAUDE Entry Details

• Report Number: 2015691-2020-10527
• MDR Report Key: 9712274
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-02-14
• Date of Report: 2020-01-28
• Date of Event: 2020-01-27
• Date Mfgr Received: 2020-01-28
• Device Manufacturer Date: 2019-07-26
• Date Added to Maude: 2020-02-14
• 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: PHARMACIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS SAMANTHA EVELIEGH
• Manufacturer Street: 1 EDWARDS WAY
• Manufacturer City: IRVINE CA 92614
• Manufacturer Country: US
• Manufacturer Postal: 92614
• Manufacturer Phone: 9492503939
• Manufacturer G1: EDWARDS LIFESCIENCES DR
• Manufacturer Street: PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5
• Manufacturer City: HAINA, SAN CRISTOBAL
• Manufacturer Country: DR
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PRESSURE MONITORING KIT
• Generic Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Product Code: DXO
• Date Received: 2020-02-14
• Model Number: T100209B
• Catalog Number: T100209B
• Lot Number: 62484303
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EDWARDS LIFESCIENCES DR
• Manufacturer Address: PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-14