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 2018-09-06 for XPRESS LOPROFILE ENT DILATION SYSTEM MSB&LLF LPLF-106 manufactured by Entellus Medical.
[119367136]
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. However, the device history records were reviewed. All manufacturing and quality assurance testing was carried out in accordance with standard procedure, and the device met specification at the time of release. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119367137]
It was reported that after a right frontal balloon dilation with an xpress balloon device and followed by a full fess of the frontal, sphenoid, maxillary and ethmoid sinuses with septoplasty and bilateral turbinate reduction a csf leak was noticed near the left frontal sinus. The csf leak was repaired with a patch using skin graft along with packing product. The patient was admitted overnight for observation and discharged home the following morning without further issues. No further patient injury or complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006345872-2018-00002 |
| MDR Report Key | 7850762 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-06 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-06-15 |
| Date Mfgr Received | 2018-06-15 |
| 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 | 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 |
| 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 BALLOON DILATION SYSTEM |
| Product Code | LRC |
| Date Received | 2018-09-06 |
| Model Number | MSB&LLF |
| Catalog Number | LPLF-106 |
| Lot Number | A15245 |
| 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, SUITE 40 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-06 |