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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-19 for * manufactured by Katena Products, Inc..

Event Text Entries

[22167216] Stent was being passed thru lacrimal duct into nasal passage, when retrieval hook broke off. Dr was able to retrieve the broken tip from the nasopharynx, and continued trying to pass stent. As the stent was coming thru, it came loose from the probe. This incident did not result in significant injury to pt, but was reported due to physician request.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 96418
• MDR Report Key: 96418
• Date Received: 1994-07-19
• Date Added to Maude: 1997-06-09
• 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
• 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: *
• Product Code: HNL
• Date Received: 1994-07-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 95191
• Manufacturer: KATENA PRODUCTS, INC.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1994-07-19