ETHICON * 5:15D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-23 for ETHICON * 5:15D manufactured by Ethicon Endo-surgery, Inc..

Event Text Entries

[539007] Left iliac vein punctured.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1040174
• MDR Report Key: 756451
• Date Received: 2006-08-23
• Date of Report: 2006-08-22
• Date of Event: 2006-08-21
• Date Added to Maude: 2006-09-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• 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 Sequence Number: 1

• Brand Name: ETHICON
• Generic Name: TROCARS 10/11MM
• Product Code: GCJ
• Date Received: 2006-08-23
• Model Number: *
• Catalog Number: 5:15D
• Lot Number: C4EM2E
• ID Number: *
• Device Expiration Date: 2011-06-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 744331
• Manufacturer: ETHICON ENDO-SURGERY, INC.
• Manufacturer Address: * CINCINNATI OH 452422839 US

Device Sequence Number: 2

• Brand Name: ETHICON
• Generic Name: TROCARS 5MM
• Product Code: GCJ
• Date Received: 2006-08-23
• Model Number: *
• Catalog Number: 355LD
• Lot Number: C4EE81
• ID Number: *
• Device Expiration Date: 2011-05-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 744336
• Manufacturer: ETHICON ENDO-SURGERY, INC.
• Manufacturer Address: * CINCINNATI OH 452422839 US

Device Sequence Number: 3

• Brand Name: ETHICON
• Generic Name: PNEUMONEEDLE 150MM
• Product Code: FHP
• Date Received: 2006-08-23
• Model Number: *
• Catalog Number: PN 150
• Lot Number: C4D24P
• ID Number: NA
• Device Expiration Date: 2010-12-01
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 3
• Device Event Key: 744342
• Manufacturer: ETHICON ENDO-SURGERY, INC
• Manufacturer Address: * CINCINNATI OH 452422839 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening	2006-08-23