MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-15 for LATERA ABSORBABLE NASAL LATANI24 manufactured by Entellus Medical, Inc..
[136487764]
At the time of this report, no further patient injury or negative health related outcomes have been reported. The device box and implant were discarded, therefore no investigation of the device was completed. Discarded by physician.
Patient Sequence No: 1, Text Type: N, H10
[136487805]
It was reported that after a successful bilateral implant of the latera absorbable nasal implant the patient experienced ongoing infections. The physician prescribed cipro, however the patient requested removal of one implant. Eighty-four (84) days post bilateral implant the patient had one absorbable nasal implant removed without complications and was discharged home. No further patient complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006345872-2019-00001 |
| MDR Report Key | 8345994 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2019-02-15 |
| 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 | LATERA ABSORBABLE NASAL |
| Generic Name | LATERA ABSORBABLE NASAL |
| Product Code | NHB |
| Date Received | 2019-02-15 |
| Model Number | LATANI24 |
| Catalog Number | LATANI24 |
| Lot Number | UNK |
| 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. Required No Informationntervention | 2019-02-15 |