MINIATURE PIN & LIGATURE CUTTER ODG1002

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 2011-08-17 for MINIATURE PIN & LIGATURE CUTTER ODG1002 manufactured by Gac International.

Event Text Entries

[2194909] In this event it was reported that the tip of a miniature pin and ligature cutter separated outside of a pt's mouth; there is no indication that injury resulted.
Patient Sequence No: 1, Text Type: D, B5


[9346720] The device was returned for eval and was found to have exceeded the expected life of the device. While no serious injury resulted in this event, there has been a previous report rec'd in past two yrs 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2086211-2011-00005
MDR Report Key2264973
Report Source05
Date Received2011-08-17
Date of Report2011-07-18
Date Mfgr Received2011-07-18
Date Added to Maude2012-06-21
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. PHILADELPHIA ST, STE 60 SUSQUEHANNA COMMERCE CTR 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 NameMINIATURE PIN & LIGATURE CUTTER
Product CodeEJB
Date Received2011-08-17
Returned To Mfg2011-08-11
Catalog NumberODG1002
Lot Number03-43
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGAC INTERNATIONAL
Manufacturer AddressBOHEMIA NY US


Patients

Patient NumberTreatmentOutcomeDate
10 2011-08-17

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