MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-12-11 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[18275683]
Intersect ent was notified on (b)(6) 2012 of an event that occurred on (b)(6) 2012 for an insulin dependent diabetic patient treated with revision fess, including bilateral ethmoidectomies, maxillary antrostomies and frontal sinusotomies. Propel implants were placed in the right and left ethmoid sinuses. Surgiflo hemostatic agent was also used. Three weeks post-op the patient experienced symptoms of sinusitis and had developed peri-orbital cellulitis on the right side. Physician performed routine post-surgical debridement. The physician prescribed antibiotics to treat the infection. The patient's infection cleared and patient was asymptomatic after taking the antibiotics. Since infections have the potential to be more serious in the diabetic patient population, the company is taking a conservative approach in reporting this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008301917-2012-00001 |
| MDR Report Key | 2871685 |
| Report Source | 05,07 |
| Date Received | 2012-12-11 |
| Date of Report | 2012-12-11 |
| Date of Event | 2012-03-22 |
| Date Mfgr Received | 2012-03-22 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2013-01-22 |
| 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 | 1049 ELWELL COURT |
| Manufacturer City | PALO ALTO CA 94303 |
| Manufacturer Country | US |
| Manufacturer Postal | 94303 |
| Manufacturer Phone | 6506412115 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPEL SINUS IMPLANT |
| Generic Name | DRUG-ELUTING SINUS STENT |
| Product Code | OWO |
| Date Received | 2012-12-11 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | 11208001 |
| Device Expiration Date | 2012-12-11 |
| 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 | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-11 |