ULTRA SAFETY PLUS 30G 25MM-2.2 ML

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-09-20 for ULTRA SAFETY PLUS 30G 25MM-2.2 ML manufactured by Septodont.

MAUDE Entry Details

Report Number9610964-2019-00007
MDR Report Key9098443
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2019-09-20
Date of Report2019-10-16
Date of Event2019-08-19
Date Mfgr Received2019-09-19
Date Added to Maude2019-09-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer Street58, RUE DU PONT DE CRETEIL
Manufacturer CitySAINT MAUR DES FOSSESS, 94107
Manufacturer CountryFR
Manufacturer Postal94107
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameULTRA SAFETY PLUS
Generic NameULTRA SAFETY PLUS
Product CodeDZM
Date Received2019-09-20
Model Number30G 25MM-2.2 ML
Lot NumberF51069AA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSEPTODONT
Manufacturer Address58, RUE DU PONT DE CRETEIL SAINT MAUR, CEDEX VAL-DE-MARNE, 94107 FR 94107


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-09-20

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