NASAL SNARE WIRE * 070705

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,08 report with the FDA on 2002-12-24 for NASAL SNARE WIRE * 070705 manufactured by Karl August Huber Gmbh.

Event Text Entries

[286345] The user facility reported that a nasal snare wire broke intraoperatively. No injuries were reported due to this incident.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2515651-2002-00010
• MDR Report Key: 435285
• Report Source: 01,05,06,08
• Date Received: 2002-12-24
• Date Mfgr Received: 2002-06-12
• Date Added to Maude: 2003-01-03
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: BRADLEY SEIDEN, MGR.
• Manufacturer Street: 200 PRECISION RD. SUITE 200
• Manufacturer City: HORSHAM PA 19044
• Manufacturer Country: US
• Manufacturer Postal: 19044
• Manufacturer Phone: 2154428892
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NASAL SNARE WIRE
• Generic Name: NASAL SNARE WIRE, 8 GAUGE, THROAT
• Product Code: KBE
• Date Received: 2002-12-24
• Model Number: *
• Catalog Number: 070705
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 424221
• Manufacturer: KARL AUGUST HUBER GMBH
• Manufacturer Address: FREIBURGSTRASSE 32 TUTTLINGEN GM 78532
• Baseline Brand Name: NASAL SNARE WIRE
• Baseline Generic Name: NASAL SNARE WIRE, 8 GAUGE, THROAT
• Baseline Model No: *
• Baseline Catalog No: 070705
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-12-24