MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-09-06 for XPRESS ULTRA ENT DILATION SYSTEM MSB&LLF ULF-106 manufactured by Entellus Medical, Inc..
[119389959]
At the time of this report, no further patient injury or negative health related outcomes have been reported. The device was discarded after the procedure and the lot number was not provided. Therefore, no investigation of the device was completed. Device was discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[119389960]
It was reported that a patient experienced subcutaneous emphysema in the head, neck, and chest. After the physician successfully completed bilateral eustachian tube dilation, the patient was discharged home. On postoperative day 1, the patient reported sneezing vigorously while lifting 30 to 40 lbs at work and subsequently developing bilateral facial and neck swelling. The patient had a cat scan and was found to have subcutaneous emphysema of the head, neck, and chest with significant pneumomediastinum. Patient was put on sinus precautions (no nose blowing, lifting >5 lbs, drinking through straws, coughing, or sneezing with mouth closed). The patient's subcutaneous emphysema improved over 48 hours without intervention, and the patient was discharged home. No further patient injury or complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006345872-2018-00003 |
| MDR Report Key | 7851535 |
| Report Source | LITERATURE |
| Date Received | 2018-09-06 |
| Date of Report | 2018-09-06 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-09-06 |
| 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 | SINUS BALLON DILATION SYSTEM |
| Product Code | PNZ |
| Date Received | 2018-09-06 |
| Model Number | MSB&LLF |
| Catalog Number | ULF-106 |
| Lot Number | UNKNOWN |
| 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 | 2018-09-06 |