OUTBACK ELITE 120CM RE-ENTRY N/A OTB59120A

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 2019-11-07 for OUTBACK ELITE 120CM RE-ENTRY N/A OTB59120A manufactured by Cordis De Mexico.

MAUDE Entry Details

• Report Number: 9616099-2019-03338
• MDR Report Key: 9290045
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-11-07
• Date of Report: 2019-11-22
• Date of Event: 2019-10-19
• Date Mfgr Received: 2019-11-20
• Device Manufacturer Date: 2019-05-13
• Date Added to Maude: 2019-11-07
• 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: KARLA CASTRO
• Manufacturer Street: 14201 NW 60TH AVE
• Manufacturer City: MIAMI LAKES FL 33014
• Manufacturer Country: US
• Manufacturer Postal: 33014
• Manufacturer Phone: 7863138372
• Manufacturer G1: CORDIS DE MEXICO
• Manufacturer Street: CIRCUITO INT NTE 1820
• Manufacturer City: JUAREZ 32575
• Manufacturer Country: MX
• Manufacturer Postal Code: 32575
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OUTBACK ELITE 120CM RE-ENTRY
• Generic Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Product Code: PDU
• Date Received: 2019-11-07
• Model Number: N/A
• Catalog Number: OTB59120A
• Lot Number: 17860363
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CORDIS DE MEXICO
• Manufacturer Address: CIRCUITO INT NTE 1820 JUAREZ 32575 MX 32575

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-07