MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-12 for XPRESS LOPROFILE ENT DILATION SYSTEM MSB&LLF LPLF-106 manufactured by Entellus Medical.
[105329052]
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. The device was discarded after the procedure and the lot number was not provided. Therefore, no investigation of the device was completed.
Patient Sequence No: 1, Text Type: N, H10
[105329053]
It was reported that a patient experienced subcutaneous emphysema of the lower face. After the physician successfully completed a left side eustachian tube dilation, the patient was discharged home. Two (2) days later the patient experienced left sided facial swelling/inflammation and was examined by her physician. The patient had a cat scan and was found to have subcutaneous emphysema of the lower face. The patient was given a prescription of cipro and prednisone and was sent home. The patient is doing well with no further complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006345872-2018-00001 |
| MDR Report Key | 7426517 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-12 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-03-16 |
| Date Mfgr Received | 2018-03-16 |
| Date Added to Maude | 2018-04-12 |
| 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 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7634637066 |
| Manufacturer G1 | ENTELLUS MEDICAL |
| Manufacturer Street | 3600 HOLLY LN N, 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 LOPROFILE ENT DILATION SYSTEM |
| Generic Name | SINUS BALLON DILATION SYSTEM |
| Product Code | PNZ |
| Date Received | 2018-04-12 |
| Model Number | MSB&LLF |
| Catalog Number | LPLF-106 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTELLUS MEDICAL |
| Manufacturer Address | 3600 HOLLY LN N PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-12 |