MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-20 for ENTACT 601-00100 manufactured by Arthrocare Corp..
[4300478]
While surgeon was using the entrigue entact septal stapler, the stapler tore through the patient's nasal septum requiring repair and reconstruction by the surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3676709 |
| MDR Report Key | 3676709 |
| Date Received | 2014-02-20 |
| Date of Report | 2014-02-20 |
| Date of Event | 2014-02-11 |
| Report Date | 2014-02-20 |
| Date Reported to FDA | 2014-02-20 |
| Date Reported to Mfgr | 2014-03-13 |
| Date Added to Maude | 2014-03-13 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Brand Name | ENTACT |
| Generic Name | SEPTAL STAPLER/ABSORBABLE STAPLES |
| Product Code | OLL |
| Date Received | 2014-02-20 |
| Model Number | 601-00100 |
| Catalog Number | 601-00100 |
| Lot Number | 310005 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROCARE CORP. |
| Manufacturer Address | 7000 W WILLIAM CANNON DR BLDG 1 AUSTIN TX 78735 US 78735 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-20 |