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.
[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
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 |
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 | * |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2002-12-24 |