TOOTH CONDITIONER GEL 646125

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2001-10-22 for TOOTH CONDITIONER GEL 646125 manufactured by L.d. Caulk.

Event Text Entries

[231663] A dentist was having trouble extruding tooth conditioner gel from the syringe. Dentist pressed so hard on the syringe that the tip came off of the syringe and material went into the patient's mouth. The material was suctioned out immediately. The pt did not experience any discomfort and there was no injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2515379-2001-00018
MDR Report Key358232
Report Source00,05
Date Received2001-10-22
Date of Report2001-10-22
Date of Event2001-09-05
Date Mfgr Received2001-09-06
Date Added to Maude2001-10-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactWILLIAM FREY, JR.
Manufacturer Street570 W. COLLEGE AVENUE P.O. BOX 872
Manufacturer CityYORK PA 174050872
Manufacturer CountryUS
Manufacturer Postal174050872
Manufacturer Phone7178457511
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTOOTH CONDITIONER GEL
Generic NameDENTAL RESTORATIVE MATERIAL
Product CodeEBC
Date Received2001-10-22
Model NumberNA
Catalog Number646125
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key347441
ManufacturerL.D. CAULK
Manufacturer Address38 W. CLARKE AVENUE P.O. BOX 359 MILFORD DE 199630359 US
Baseline Brand NameCAULK TOOTH CONDITION GEL 34%
Baseline Generic NamePIT AND FISSURE SEALANT AND CONDITIONER
Baseline Model NoNA
Baseline Catalog No646125
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life Contained*
Baseline Shelf Life [Months]*
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK942031
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2001-10-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.