MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-07-02 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[3632113]
Intersect ent was notified on (b)(4) 2013, of a patient that was reported to have experienced mt lateralization and the return of symptoms 3 weeks following sinus surgery and placement of propel. Patient is scheduled for in-office procedures to correct left sides symptoms. The company is taking a conservative approach in reporting this event.
Patient Sequence No: 1, Text Type: D, B5
[10886232]
Middle turbinate lateralization is a condition that may occur post fess. Mild to moderate middle turbinate lateralization is not likely to cause any detrimental effect in patients. It may impair direct visualization of the sinus cavity, however, will not impair breathing. Severe middle turbinate lateralization may cause obstruction of the sinus drainage, thereby, increasing the chances of recurrent sinus infection. It is not likely that mt lateralization by itself may cause or contribute to permanent impairment of body function or permanent damage to a body structure which would necessitate medical intervention beyond routine care, however, this patient will be undergoing lysis of left nasal synechiae as well as balloon dilation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008301917-2013-00002 |
| MDR Report Key | 3207228 |
| Report Source | 05,07 |
| Date Received | 2013-07-02 |
| Date of Report | 2013-07-02 |
| Date Mfgr Received | 2013-04-26 |
| Date Added to Maude | 2013-07-08 |
| 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 SINUS IMPLANT |
| Product Code | OWO |
| Date Received | 2013-07-02 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | 20309001 |
| 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 | 2013-07-02 |