MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-04-23 for UNK TONSIL SNARE WIRE UNK WIRE manufactured by Cardinal Health.
[19960228]
While removing the patient's tonsil using a snare, the snare wire broke. All of the wire except for a small piece was retrieved. The physician was immediately notified that a small segment of the snare wire was missing. A thorough laryngoscopy was performed. No foreign body was visualized and chest and neck x-ray were negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2004-00033 |
| MDR Report Key | 551919 |
| Report Source | 05 |
| Date Received | 2004-04-23 |
| Date of Report | 2004-04-23 |
| Date Mfgr Received | 2004-03-31 |
| Date Added to Maude | 2004-10-29 |
| 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 | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 6038903311 |
| Manufacturer G1 | V. MUELLER |
| Manufacturer Street | 1250 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK TONSIL SNARE WIRE |
| Generic Name | UNK TONSIL SNARE WIRE |
| Product Code | KZB |
| Date Received | 2004-04-23 |
| Model Number | UNK WIRE |
| Catalog Number | UNK WIRE |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 541447 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | UNK TONSIL SNARE WIRE |
| Baseline Generic Name | UNL TONSIL SNARE WIRE |
| Baseline Model No | UNK WIRE |
| Baseline Catalog No | UNK WIRES |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-23 |