BARRON K20-2079 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-13 for BARRON K20-2079 * manufactured by Katena Products, Inc..

Event Text Entries

[87879] Defect in the corneal punch caused the cornea transplant tissue to be cut inaccurately and could not be used.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012817
• MDR Report Key: 144668
• Date Received: 1998-01-13
• Date of Report: 1998-01-07
• Date of Event: 1998-01-07
• Date Added to Maude: 1998-01-22
• 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: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BARRON
• Generic Name: CORNEAL PUNCH
• Product Code: HNJ
• Date Received: 1998-01-13
• Model Number: K20-2079
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 141054
• Manufacturer: KATENA PRODUCTS, INC.
• Manufacturer Address: 4 STEWART CT. DENVILLE NJ 07834 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-01-13