MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-11 for XPRESS ULTRA ENT DILATION SYSTEM ULF-106 manufactured by Entellus Medical, Inc..
| Report Number | 3006345872-2020-00003 |
| MDR Report Key | 9820079 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KAREN PETERSON |
| Manufacturer Street | 3600 HOLLY LANE NORTH SUITE 40 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7634637066 |
| Manufacturer G1 | ENTELLUS MEDICAL, INC. |
| Manufacturer Street | 3600 HOLLY LANE NORTH SUITE 40 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPRESS ULTRA ENT DILATION SYSTEM |
| Generic Name | EUSTACHIAN TUBE BALLOON DILATION DEVICE |
| Product Code | PNZ |
| Date Received | 2020-03-11 |
| Catalog Number | ULF-106 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTELLUS MEDICAL, INC. |
| Manufacturer Address | 3600 HOLLY LANE NORTH SUITE 40 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |