MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for PROPEL CONTOUR MOMETASONE FUROATE IMPLANTABLE 50011 manufactured by Intersect Ent.
[185517283]
There was no harm to the patient. The surgeon, while attempting to deploy the device, was notified it was not working correctly. The device was removed from the field and another device obtained. The faulty device was sequestered to provide to the rep/vendor for replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9896920 |
| MDR Report Key | 9896920 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-13 |
| Report Date | 2020-03-27 |
| Date Reported to FDA | 2020-03-27 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPEL CONTOUR MOMETASONE FUROATE IMPLANTABLE |
| Generic Name | DRUG-ELUTING SINUS STENT |
| Product Code | OWO |
| Date Received | 2020-03-30 |
| Catalog Number | 50011 |
| Lot Number | 90429002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSECT ENT |
| Manufacturer Address | 1555 ADAMS DRIVE MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |