MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for AA IMPLANT SINUS PROPEL 23MM AA70011 70011 manufactured by Intersect Ent.
[39004526]
Pt had endoscopy of bilateral sinus by ent physician. He was told that the sinus packing would dissolve. On his way back for his post-op appointment, he was driving on the freeway and one of the packs slid down his throat, obstructing his airway. He had to manually remove it with his fingers. Fortunately there was no harm to the pt. The ent physician was not aware this was a risk, as they were suppose to dissolve. Info re: product: manufacturer: intersect ent exact name of product: propel date used: (b)(6) 2015 procedure preformed: endoscopy of sinuses for nasal polyps/sinusitis right sinus: aa implant sinus propel 23mm aa70011 serial number-n/a lot number: 50828001 catalog: 70011 exp date: 08/28/2017 left sinus: aa implant sinus propel 23mm aa70011 serial number: n/a lot number: 50828001 catalog: 70011 exp date: 08/28/2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060385 |
| MDR Report Key | 5454705 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-19 |
| Date of Event | 2015-12-01 |
| Date Added to Maude | 2016-02-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AA IMPLANT SINUS PROPEL 23MM |
| Generic Name | AA IMPLANT SINUS PROPEL 23MM |
| Product Code | OWO |
| Date Received | 2016-02-19 |
| Model Number | AA70011 |
| Catalog Number | 70011 |
| Lot Number | 50828001 |
| Device Expiration Date | 2017-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSECT ENT |
| Brand Name | AA IMPLANT SINUS PROPEL 23MM |
| Generic Name | AA IMPLANT SINUS PROPEL 23MM |
| Product Code | OWO |
| Date Received | 2016-02-19 |
| Model Number | AA70011 |
| Catalog Number | 70011 |
| Lot Number | 50828001 |
| Device Expiration Date | 2017-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | INTERSECT ENT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-19 |