FLEXITIME CORRECT FLOW 66002186

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-11 for FLEXITIME CORRECT FLOW 66002186 manufactured by Kulzer Srl.

MAUDE Entry Details

Report Number1821514-2019-00006
MDR Report Key8688662
Date Received2019-06-11
Date of Report2019-06-10
Date of Event2019-05-15
Date Facility Aware2019-05-15
Report Date2019-06-10
Date Reported to Mfgr2019-06-10
Date Added to Maude2019-06-11
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXITIME CORRECT FLOW
Generic NameIMPRESSION MATERIAL
Product CodeELW
Date Received2019-06-11
Catalog Number66002186
Lot NumberK010108
Device AvailabilityN
Device Age7 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerKULZER SRL
Manufacturer AddressDIETCH HONOLD 1 CLADERIA C3 SACALAZ-JUDETUL, 307370 RO 307370


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-06-11

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