PALODENT 659500

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 2004-10-29 for PALODENT 659500 manufactured by Dentsply Caulk.

Event Text Entries

[684695] Doctor reported a malfunction of ring placement forceps caused ring to fall into patient's mouth. Patient did not swallow ring and there is no report of injury.
Patient Sequence No: 1, Text Type: D, B5


[7878468] While there was no injury reported in this case, a previous report was filed pertaining to irreversible damage to a tooth requiring intervention, thereby establishing that the malfunction is likely to cause or contribute to a death or serious injury. Therefore, this event is reportable. Further testing will be performed on the returned device and results will be reported as they become available. Results of the dhr review are attached.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2515379-2004-00480
MDR Report Key910310
Report Source05
Date Received2004-10-29
Date of Report2004-09-30
Date of Event2004-09-30
Date Mfgr Received2004-09-30
Device Manufacturer Date2004-01-01
Date Added to Maude2007-09-12
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 Location0
Manufacturer ContactDR. PATRICIA KIHN
Manufacturer StreetSUSQUEHANNA COMMERCE CENTER W. 221 W. PHILA. ST., STE. 60
Manufacturer CityYORK PA 17404
Manufacturer CountryUS
Manufacturer Postal17404
Manufacturer Phone7178457511
Manufacturer G1DENTSPLY CAULK
Manufacturer Street38 W. CLARKE AVE.
Manufacturer CityMILFORD DE 19963
Manufacturer CountryUS
Manufacturer Postal Code19963
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePALODENT
Generic NameSECTIONAL MATRIX SYSTEM, PLACEMENT FORCEPS
Product CodeEJG
Date Received2004-10-29
Returned To Mfg2004-10-24
Model NumberNA
Catalog Number659500
Lot Number040126 (INVALID)
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key884068
ManufacturerDENTSPLY CAULK
Manufacturer Address* MILFORD DE * US


Patients

Patient NumberTreatmentOutcomeDate
10 2004-10-29

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