DISTAL END CUTTER BIG JOHN 1016U

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 2010-07-15 for DISTAL END CUTTER BIG JOHN 1016U manufactured by Gac International.

Event Text Entries

[1367035] It was reported that the tip of a distal end cutter separated in a patient's mouth; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


[8610626] While no serious injury resulted in this event, there has been a previous report received in the past two years involving a similar device where this malfunction resulted in a serious injury. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for evaluation, though has not been returned as of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2086211-2010-00101
MDR Report Key1765968
Report Source05
Date Received2010-07-15
Date of Report2010-06-16
Date of Event2010-06-10
Date Mfgr Received2010-06-16
Date Added to Maude2011-02-11
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 FDA0
Event Location0
Manufacturer ContactHELEN LEWIS
Manufacturer Street221 W. PHILA. ST., STE. 60 SUSQUEHANNA COMMERCE CENTER W.
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457511
Manufacturer G1ORTHODENTAL INTL., INC.
Manufacturer Street2306 M.L. KING SUITE 1
Manufacturer CityCALEXICO CA 92231
Manufacturer CountryUS
Manufacturer Postal Code92231
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDISTAL END CUTTER
Product CodeEJB
Date Received2010-07-15
Catalog NumberBIG JOHN 1016U
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerGAC INTERNATIONAL
Manufacturer AddressBOHEMIA NY US


Patients

Patient NumberTreatmentOutcomeDate
116 2010-07-15

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