EXTERNAL NASAL SPLINT - MEDIUM 1528120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-27 for EXTERNAL NASAL SPLINT - MEDIUM 1528120 manufactured by Medtronic Xomed Inc..

Event Text Entries

[131535298] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[131535299] A health care provider (hcp) reported via manufacturer representative that the external nasal splint created an injury post-operatively in the place that it had been used. There was no delay in the surgical procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1045254-2018-00734
MDR Report Key8200619
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-12-27
Date of Report2018-12-27
Date of Event2018-12-03
Date Mfgr Received2018-12-03
Device Manufacturer Date2018-03-14
Date Added to Maude2018-12-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactURIZA SHUMS
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328405
Manufacturer G1MEDTRONIC XOMED INC.
Manufacturer Street6743 SOUTHPOINT DR N
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal Code32216
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEXTERNAL NASAL SPLINT - MEDIUM
Generic NameSPLINT, INTRANASAL SEPTAL
Product CodeLYA
Date Received2018-12-27
Model Number1528120
Catalog Number1528120
Lot Number0215072839
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC XOMED INC.
Manufacturer Address6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-12-27

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