MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-30 for SNOWDEN PENCER COTTLE MOELLER A-3 88-3873 manufactured by Bd V. Mueller.
[64025753]
Cottle elevator used in ent surgery broke during sinus surgery. The surgeon retrieved the broken piece with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067056 |
| MDR Report Key | 6225085 |
| Date Received | 2016-12-30 |
| Date of Report | 2016-12-30 |
| Date of Event | 2016-12-19 |
| Date Added to Maude | 2017-01-05 |
| 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 | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SNOWDEN PENCER COTTLE |
| Generic Name | SEPTUM ELEVATOR |
| Product Code | KAD |
| Date Received | 2016-12-30 |
| Model Number | MOELLER A-3 |
| Catalog Number | 88-3873 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD V. MUELLER |
| Manufacturer Address | FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-30 |