PALODENT PLUS FORCEPS 659810

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-11 for PALODENT PLUS FORCEPS 659810 manufactured by Dentsply Caulk.

Event Text Entries

[60087898] While no serious injury resulted in this event, there has been a previous report received 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 results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10


[60087899] In this event it was reported that a pair of palodent plus forceps broke at the tip; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


[65932602] Evaluation found a micro fracture resulted due to press stroke due to very cold weather. Workshop room temperature has been improved during cold weather and further micro inspections are carried out.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2515379-2016-00027
MDR Report Key6095036
Date Received2016-11-11
Date of Report2017-01-18
Date Mfgr Received2016-12-21
Date Added to Maude2016-11-11
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 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 CAULK
Manufacturer Street38 W. CLARK AVE.
Manufacturer CityMILFORD DE 19963
Manufacturer CountryUS
Manufacturer Postal Code19963
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePALODENT PLUS FORCEPS
Generic NameINSTRUMENTS, DENTAL HAND
Product CodeDZN
Date Received2016-11-11
Returned To Mfg2016-10-11
Model NumberNA
Catalog Number659810
Lot NumberD0312
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY CAULK
Manufacturer Address38 W. CLARK AVE. MILFORD DE 19963 US 19963


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-11

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