400 DENTAL NDL 30SH 8881400074

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-10-17 for 400 DENTAL NDL 30SH 8881400074 manufactured by Covidien.

MAUDE Entry Details

Report Number1017768-2019-00706
MDR Report Key9204764
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-10-17
Date of Report2019-10-24
Date of Event2019-09-30
Date Mfgr Received2019-10-08
Date Added to Maude2019-10-17
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer Street2010 EAST INTERNATIONAL SPEEDW
Manufacturer CityDELAND FL 32724
Manufacturer CountryUS
Manufacturer Postal Code32724
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name400 DENTAL NDL 30SH
Generic NameNEEDLE, DENTAL
Product CodeDZM
Date Received2019-10-17
Model Number8881400074
Catalog Number8881400074
Lot Number832343
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2010 EAST INTERNATIONAL SPEEDW DELAND FL 32724 US 32724


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-17

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