MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-04 for LOPROFILE 6X20MM LPLF-106 manufactured by Entellus Medical, Inc..
[182016661]
After the procedure the patient's roommate informed the physician that the patient had been feeling sick, was taking otc cold medications in the days prior to the procedure and felt lightheaded at times. It was discovered after the procedure that the patient had a urology procedure the day prior to the balloon procedure. It was reported that the physician does not feel the event was related to the device or balloon dilation procedure. The device was discarded after the procedure and the lot number was not provided/known. Therefore, no investigation of the device was completed. Device was discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[182016662]
It was reported that during a balloon dilation office procedure, bilateral frontal sinuses were treated without incident. Left sphenoid dilation was completed with two dilations. The health care provider turned to the right sphenoid and abnormal bleeding was observed when the patient coughed. The patient was packed then lost consciousness and vital signs dropped. The patient was hospitalized and on life support. While on life support the patient was declared brain dead. Physician stated the event is unrelated to the balloon procedure or device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006345872-2020-00001 |
| MDR Report Key | 9788153 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | LOPROFILE 6X20MM |
| Generic Name | XPRESS ENT DILATION SYSTEM |
| Product Code | LRC |
| Date Received | 2020-03-04 |
| 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, INC. |
| Manufacturer Address | 3600 HOLLY LANE NORTH SUITE 40 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-04 |