RAD 40 1884006EM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-31 for RAD 40 1884006EM * manufactured by Medtronic.

Event Text Entries

[1864174] Md was using medtronic sinus disposable items. Rotable fusion rad 40 ref#1884006em. Item broke during use. The inner cannula snapped and made the outer cannula wobbly. A second one was given to dr. To use and it broke also. Caused no harm to patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number2054952
MDR Report Key2054952
Date Received2011-03-31
Date of Report2011-03-31
Date of Event2011-02-28
Report Date2011-03-31
Date Reported to FDA2011-03-31
Date Added to Maude2011-04-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameRAD 40
Generic NameBLADE, FRONTAL SINUS
Product CodeKAZ
Date Received2011-03-31
Returned To Mfg2011-03-01
Model Number1884006EM
Catalog Number*
Lot Number66223000
ID Number*
OperatorPHYSICIAN
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC
Manufacturer Address6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US 32216

Device Sequence Number: 2

Brand NameRAD 40
Generic NameBLADE, FRONTAL SINUS
Product CodeKAZ
Date Received2011-03-31
Returned To Mfg2011-03-01
Model Number1884006EM
Catalog Number*
Lot Number69934900
ID Number*
Device AvailabilityR
Device Sequence No2
Device Event Key0
ManufacturerMEDTRONIC
Manufacturer Address6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US 32216

Patients

Patient NumberTreatmentOutcomeDate
10 2011-03-31
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