TOOTH CONDITIONER GEL SYRINGE 646125

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-09-12 for TOOTH CONDITIONER GEL SYRINGE 646125 manufactured by Dentsply Caulk.

Event Text Entries

[273701] The complaint could not be reproduced when return samples (where provided) and/or retain samples were evaluated. Therefore, co did not positively identify any failure mode or mechanism.
Patient Sequence No: 1, Text Type: D, B5


[15686785] Doctor's office called to report that the tooth conditioning gel was clogging in the tips of the syringes that they had recently ordered. The office then tried using the new tips on a used syringe and clogging still occurred when the user tried to express the gel.
Patient Sequence No: 1, Text Type: D, B5


[18917706] Tips were attached to the syringes and the syringes were then extruded. There is no formally documented method for this extrusion test; it is generally associated with appearance method gm-062-89.
Patient Sequence No: 1, Text Type: D, B5


[18917707] Since the alleged defect could not be reproduced internally, co's conclusion is that the doctor did not properly attach the tip to the filled syringe. Also, the directions for use state "gel should flow freely with gentle pressure. Do not use excessive force. If not , remove syringe from pt field and check for obstruction. " failure to follow these instructions could lead to the complaints of tips coming off. The directions for use also state to "discard needles after use, as needles may clog if gel is allowed to dry inside. " clogged tips could create the need for excessive force, leading to potential failure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2515379-2002-00041
MDR Report Key417299
Report Source05
Date Received2002-09-12
Date of Report2002-08-15
Date Mfgr Received2002-08-15
Device Manufacturer Date2002-05-01
Date Added to Maude2002-09-20
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 ContactDR. PATRICIA KIHN
Manufacturer Street570 W. COLLEGE AVENUE
Manufacturer CityYORK PA 17405
Manufacturer CountryUS
Manufacturer Postal17405
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 SYRINGE
Generic NameDENTAL TOOTH CONDITIONER
Product CodeEBC
Date Received2002-09-12
Returned To Mfg2002-09-12
Model NumberNA
Catalog Number646125
Lot Number020520
ID NumberNA
Device Expiration Date2004-05-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key406349
ManufacturerDENTSPLY CAULK
Manufacturer Address38 WEST CLARK AVENUE 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 2002-09-12

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