MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-07-25 for PROPEL (MOMETASONE FUROTE IMPLANT 370 UG) 70011 manufactured by Intersect Ent.
[15908363]
On (b)(6) 2014 a (b)(6) pt underwent endoscopic sinus surgery with ethmoidectomy and a propel sinus implant was placed in the right ethmoid sinus. The pt was placed on an antibiotic regimen and daily neilmed sinus rinse irrigations starting day one after his procedure. On (b)(6) 2014 the physician noted a superficial fungal infection in the right ethmoid sinus during follow up. The pt complained of sever pain during debridement in the operating room under anesthesia and removed the implant. The pt was discharged with antibiotics and anti-fungal therapy. On (b)(6) 2014 physician reported the fungal infection had fully resolved and there was no sign of chronic infection, and the sinus was healing as expected.
Patient Sequence No: 1, Text Type: D, B5
[16063065]
Based on the company's complaint investigation, the device met its specs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010101669-2014-00003 |
| MDR Report Key | 3987593 |
| Report Source | 05,07 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-25 |
| Date of Event | 2014-06-06 |
| Date Mfgr Received | 2014-06-25 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-08-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AMY WOLBECK |
| Manufacturer Street | 1555 ADAMS DR |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506412115 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPEL (MOMETASONE FUROTE IMPLANT 370 UG) |
| Generic Name | DRUG ELUTING SINUS STENT |
| Product Code | OWO |
| Date Received | 2014-07-25 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | 40325001 |
| Device Expiration Date | 2015-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSECT ENT |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-25 |