MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-11 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[3909655]
A patient developed a severe post-op fungal infection two weeks after sinus surgery for treatment of chronic sinusitis in which propel implants were placed bilaterally in the ethmoid sinuses. Culture identified as aspergillus fungus. On (b)(6) 2013 the physician performed surgery to remove the implant and correct the infection. The patient was noted as doing well two weeks following surgery.
Patient Sequence No: 1, Text Type: D, B5
[11164278]
At the time of this report, no further patient injury or negative health related outcomes have been reported. Reference mdr# 3010101669-2013-00004.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010101669-2013-00006 |
| MDR Report Key | 3423262 |
| Report Source | 05 |
| Date Received | 2013-10-11 |
| Date of Report | 2013-08-30 |
| Date of Event | 2013-08-05 |
| Date Mfgr Received | 2013-08-30 |
| Date Added to Maude | 2013-10-23 |
| 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 | 2013-10-11 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | 30213002 |
| ID Number | DEVICE #2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-10-11 |