MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-09-27 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[3921481]
A patient reported severe headache two weeks after sinus surgery for treatment of chronic sinusitis in which propel implants were placed bilaterally in the ethmoid sinuses. Physician performed in office debridement, noticed fungus on the implant in the right ethmoid sinus and prescribed antibiotics. The patient was then prescribed the anti-fungal drug spornox at the third week post-surgery follow-up visit. At the fourth week post-surgery follow-up visit the physician performed debridement on both sides in the operating room and removed the implants and the presence of fungus was noted. The patient is doing well with no further complications.
Patient Sequence No: 1, Text Type: D, B5
[11189265]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010101669-2013-00003 |
| MDR Report Key | 3379072 |
| Report Source | 05,07 |
| Date Received | 2013-09-27 |
| Date of Report | 2013-09-27 |
| Date of Event | 2013-08-30 |
| Date Mfgr Received | 2013-08-30 |
| Date Added to Maude | 2013-10-17 |
| 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 SINUS IMPLANT |
| Product Code | OWO |
| Date Received | 2013-09-27 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| 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 | 2013-09-27 |