MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-09-19 for PROPEL (MOMETASONE FUROATE IMPLANT 370 UG) 70011 manufactured by Intersect Ent.
[19402369]
On (b)(6) 2014, a (b)(6) year old male with a history of chronic sinus disease and asthma underwent endoscopic sinus surgery and two propel sinus implants were placed bilaterally in the ethmoid sinuses. The pt was placed on antibiotics for 10 days post operatively. On day one, post-op packing was removed and daily saline sinus irrigations were started. On (b)(6) 2014 (2 weeks post-op) the pt complained of significant headache, decrease in visual acuity, and ocular pain. During the 2 week post-operative visit, the physician observed both peri-orbital and lamina papyracea inflammation; he opted to remove the implants and placed the pt on oral steroids. The pt was referred to an ophthalmologist, who did not observed any ocular pathology or prescribed any additional medications. A ct scan was performed and it was reported on (b)(6) 2014, that the sinuses were clear of any subsequent issues. The pt's eye symptoms had lessened, however he continued to experience headaches. This report is based on info available to the company at the time the report was due for submission and may not reflect all info that may ultimately become available through requests or analysis.
Patient Sequence No: 1, Text Type: D, B5
[19533060]
Based on a review of internal records, the company was not able to establish a failure to meet specification. However, out of an abundance of caution, the company is submitting the report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010101669-2014-00005 |
| MDR Report Key | 4117509 |
| Report Source | 05,07 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-08-22 |
| Date of Event | 2014-08-21 |
| Date Mfgr Received | 2014-08-22 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2014-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 FUROATE IMPLANT 370 UG) |
| Generic Name | DRUG ELUTING SINUS STENT |
| Product Code | OWO |
| Date Received | 2014-09-19 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | 40520001 |
| Device Expiration Date | 2015-11-20 |
| 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 | 2014-09-19 |