MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-24 for XPRESS LOPROFILE ENT DILATION SYSTEM MSB LPLF-106 manufactured by Entellus Medical.
[80864300]
The device was discarded after the procedure. Therefore, no investigation was completed. At the time of this report, no further patient injury or negative health related outcomes have been reported. Entellus medical will continue to monitor this situation and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: N, H10
[80864301]
It was reported that a patient experienced bilateral subcutaneous emphysema of the head/neck. After the physician successfully completed bilateral eustachian tube dilation without complications, the patient was discharged home. Nine (9) days later the patient was re-admitted for bilateral subcutaneous emphysema. The patient was given a course of iv antibiotics and discharged home four (4) days later. No further patient injury or complications have been reported and the patient is fully recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006345872-2017-00002 |
| MDR Report Key | 6737816 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-24 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-05-25 |
| Date Mfgr Received | 2017-05-26 |
| Date Added to Maude | 2017-07-24 |
| 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 | MRS. KAREN PETERSON |
| Manufacturer Street | 3600 HOLLY LN N, SUITE 40 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7634637066 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPRESS LOPROFILE ENT DILATION SYSTEM |
| Generic Name | SINUS BALLOON DILATION SYSTEM |
| Product Code | PNZ |
| Date Received | 2017-07-24 |
| Model Number | MSB |
| Catalog Number | LPLF-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 |
| Manufacturer Address | 3600 HOLLY LN N, SUITE 40 PLYMOUTH 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-07-24 |