MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-04-05 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[15426987]
Intersect ent was notified on (b)(6) 2013, of a pt that was reported to have experienced "severe scarring" approximately two months following sinus surgery and placement of propel.
Patient Sequence No: 1, Text Type: D, B5
[15602193]
The company has made multiple unsuccessful requests for add'l info regarding the pt's medical history and current status, the event, and the device. (note that the device cannot be returned for evaluation because it is a resorbable drug-eluting sinus stent. ) the company has reached out to the surgeon to request add'l detail regarding this event, but has not rec'd any add'l info at this time. The surgeon indicated that he believes the pt will need revision surgery, but it is unk at this time, whether the pt has had or will have revision surgery or whether the pt rec'd any other treatment. Due to the limited amount of info that the company currently possesses regarding this reported event, it is not possible to perform a full causation assessment at this time. It remains unk what role, if any, propel played in this event. This report will be supplemented as necessary as add'l info is rec'd.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008301917-2013-00001 |
| MDR Report Key | 3049552 |
| Report Source | 05,07 |
| Date Received | 2013-04-05 |
| Date of Report | 2013-04-05 |
| Date Mfgr Received | 2013-03-06 |
| Date Added to Maude | 2013-04-11 |
| 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 |
| Product Code | OWO |
| Date Received | 2013-04-05 |
| 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 | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-05 |