GUTTACORE OBTURATOR (PINK) GCP02026

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-11-13 for GUTTACORE OBTURATOR (PINK) GCP02026 manufactured by Dentsply Tulsa Dental Specialties.

Event Text Entries

[31076556] There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. This report is for the first patient. The device was not returned for evaluation and the lot number was not provided for retained product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10


[31076557] It was reported that a doctor inadvertently extruded guttacore beyond the apex of two patients; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2320721-2015-00023
MDR Report Key5221366
Report SourceHEALTH PROFESSIONAL
Date Received2015-11-13
Date of Report2015-10-13
Date Mfgr Received2015-10-13
Date Added to Maude2015-11-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMRS. HELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494229
Manufacturer G1DENTSPLY TULSA DENTAL SPECIALTIES
Manufacturer Street608 ROLLING HILLS DRIVE
Manufacturer CityJOHNSON CITY TN 37604
Manufacturer CountryUS
Manufacturer Postal Code37604
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGUTTACORE OBTURATOR (PINK)
Generic NameGUTTA-PERCHA
Product CodeEKM
Date Received2015-11-13
Model NumberNA
Catalog NumberGCP02026
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY TULSA DENTAL SPECIALTIES
Manufacturer Address608 ROLLING HILLS DRIVE JOHNSON CITY TN 37604 US 37604


Patients

Patient NumberTreatmentOutcomeDate
10 2015-11-13

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