*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-26 for * manufactured by Unk.

Event Text Entries

[18947123] Removal of portacath from left subclavian vein. No longer necessary.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 194355
• MDR Report Key: 194355
• Date Received: 1998-10-26
• Date of Report: 1998-10-20
• Date of Event: 1998-10-12
• Date Facility Aware: 1998-10-12
• Report Date: 1998-10-20
• Date Reported to FDA: 1998-10-20
• Date Added to Maude: 1998-11-02
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: PORTACATH
• Product Code: JJT
• Date Received: 1998-10-26
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 188829
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1998-10-26