LUSK DISPOSABLE ADENOID CURETTE 1423002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-10 for LUSK DISPOSABLE ADENOID CURETTE 1423002 manufactured by Medtronic Xomed, Inc..

Event Text Entries

[344388] The packaging was for the lusk disposable adenoid curette, size 2 inches. When the package was opened by the or tech, a lusk dispoable adenoid curette, size 4" was found.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number560909
MDR Report Key560909
Date Received2004-12-10
Date of Report2004-12-10
Date of Event2004-08-23
Report Date2004-12-10
Date Reported to FDA2004-12-10
Date Added to Maude2004-12-23
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLUSK DISPOSABLE ADENOID CURETTE
Generic NameADENOID CURETTE
Product CodeFZS
Date Received2004-12-10
Returned To Mfg2004-08-23
Model Number1423002
Catalog Number1423002
Lot Number3398700
ID Number*
Device AvailabilityN
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key550617
ManufacturerMEDTRONIC XOMED, INC.
Manufacturer Address6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US


Patients

Patient NumberTreatmentOutcomeDate
10 2004-12-10

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