LATERA ABSORBABLE NASAL IMPLANT UNK_INX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-09 for LATERA ABSORBABLE NASAL IMPLANT UNK_INX manufactured by Entellus Medical, Inc..

MAUDE Entry Details

Report Number3006345872-2020-00002
MDR Report Key9808484
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-09
Date of Report2020-03-09
Date of Event2020-01-01
Date Mfgr Received2020-02-12
Date Added to Maude2020-03-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KAREN PETERSON
Manufacturer Street3600 HOLLY LANE NORTH SUITE 40
Manufacturer CityPLYMOUTH MN 55447
Manufacturer CountryUS
Manufacturer Postal55447
Manufacturer Phone7634637066
Manufacturer G1ENTELLUS MEDICAL, INC.
Manufacturer Street3600 HOLLY LANE NORTH SUITE 40
Manufacturer CityPLYMOUTH MN 55447
Manufacturer CountryUS
Manufacturer Postal Code55447
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLATERA ABSORBABLE NASAL IMPLANT
Generic NameENT SYNTHETIC POLYMER
Product CodeNHB
Date Received2020-03-09
Catalog NumberUNK_INX
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENTELLUS MEDICAL, INC.
Manufacturer Address3600 HOLLY LANE NORTH SUITE 40 PLYMOUTH MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-09

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