GRACEY 9/10 CUR #6 HNDLE 70-738

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-22 for GRACEY 9/10 CUR #6 HNDLE 70-738 manufactured by Integra York, Pa Inc..

Event Text Entries

[3387867] Tip broke off, pt almost swallowed due to gag reflex (b)(6) 2013. Doctor was scaling and planing teeth when this occurred, no harm to pt.
Patient Sequence No: 1, Text Type: D, B5


[10557280] To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523190-2013-00010
MDR Report Key2999109
Report Source06
Date Received2013-02-22
Date of Report2013-02-22
Date Mfgr Received2013-02-02
Date Added to Maude2013-05-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSANDRA LEE
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer CountryUS
Manufacturer Phone6099366828
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGRACEY 9/10 CUR #6 HNDLE
Generic NameM52 - HYGIENE / PERIODONTAL
Product CodeDZP
Date Received2013-02-22
Catalog Number70-738
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer AddressYORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2013-02-22

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