MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-10 for PROPEL MINI SINUS IMPLANT 60011 manufactured by Intersect Ent.
[21089068]
A female patient underwent bilateral endoscopic sinus surgery with turbinate reduction along with septoplasty in which drug eluting sinus implants were placed bilaterally in the ethmoid sinus post-operatively. 12 days post placement, the patient phoned the physician to report the implant on the right side had migrated to her throat when she sneezed causing her to gag, a temporary sensation. The patient retrieved the implant with ease by reaching into her mouth/throat with her hand. The patient was reported to have no subsequent issues post event and no additional medical intervention was required. The same day, the patient was seen by the physician who decided to remove the left side implant.
Patient Sequence No: 1, Text Type: D, B5
[21375891]
Based on the company's complaint investigation, the device was used according to labeled indications. In an abundance of caution, intersect ent is reporting this event as a malfunction based on the information it received and the remote possibility of serious injury should a similar event occur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010101669-2015-00003 |
| MDR Report Key | 4913328 |
| Report Source | 07 |
| Date Received | 2015-07-10 |
| Date of Report | 2015-06-11 |
| Date of Event | 2015-06-10 |
| Date Mfgr Received | 2015-06-11 |
| Date Added to Maude | 2015-07-17 |
| 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 MINI SINUS IMPLANT |
| Product Code | OWO |
| Date Received | 2015-07-10 |
| Model Number | 60011 |
| Catalog Number | 60011 |
| 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 | 2015-07-10 |