COMFORT CONTROL SYRINGE 850155

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 2003-07-10 for COMFORT CONTROL SYRINGE 850155 manufactured by Dentsply Professional (midwest).

Event Text Entries

[301642] The dr reported that about half the time the units are being used, the harpoon is not engaging the rubber stopper and therefore not aspirating properly. Two patients in the last year have had epinephrine attacks and were fine after a couple of minutes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1419322-2003-00067
MDR Report Key472168
Report Source05
Date Received2003-07-10
Date of Report2003-04-28
Date Mfgr Received2003-04-28
Device Manufacturer Date2001-09-01
Date Added to Maude2003-07-18
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 17404
Manufacturer CountryUS
Manufacturer Postal17404
Manufacturer Phone7178457511
Manufacturer G1DENTSPLY PROFESSIONAL (MIDWEST)
Manufacturer Street901 WEST OAKTON ST.
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal Code60018
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMFORT CONTROL SYRINGE
Generic NameCARTRIDGE SYRINGE, DENTAL
Product CodeEJI
Date Received2003-07-10
Returned To Mfg2003-04-28
Model NumberNA
Catalog Number850155
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key461019
ManufacturerDENTSPLY PROFESSIONAL (MIDWEST)
Manufacturer Address901 WEST OAKTON ST. DES PLAINES IL 60018 US
Baseline Brand NameCOMFORT CONTROL SYRINGE
Baseline Generic NameCARTRIDGE SYRINGE, DENTAL
Baseline Model NoNA
Baseline Catalog No850155
Baseline IDNA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK002387
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-07-10

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