ELECTROTORQUE PLUS 25LPA 1002.1526

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-06-24 for ELECTROTORQUE PLUS 25LPA 1002.1526 manufactured by Kavo Dental.

Event Text Entries

[20158771] A dentist reported that a patient received a second degree burn on the inside of their right cheek during the use of a 25lpa handpiece. It was reported that the pt went to a treatment center later that evening where they were prescribed amoxicillin; 250 mg, po, codeine; 300 mg, po and an unknown ointment. Follow up with the pt in 2005 by the dentist revealed that the pt has recovered, with no further consequence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1419798-2005-00001
MDR Report Key617448
Report Source05,07
Date Received2005-06-24
Date of Report2005-04-13
Date of Event2005-04-12
Date Mfgr Received2005-04-13
Device Manufacturer Date2004-08-01
Date Added to Maude2005-06-29
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 ContactJOHN MILLER, DIRECTOR
Manufacturer Street901 WEST OAKTON ST
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal60018
Manufacturer Phone8476404924
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameELECTROTORQUE PLUS
Generic NameELECTRIC DENTAL HANDPIECE
Product CodeEKK
Date Received2005-06-24
Returned To Mfg2005-04-14
Model Number25LPA
Catalog Number1002.1526
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key607136
ManufacturerKAVO DENTAL
Manufacturer Address340 EAST MAIN ST. LAKE ZURICH IL 60047 US
Baseline Brand NameELECTROTORQUE PLUS
Baseline Generic NameELECTRIC DENTAL HANDPIECE
Baseline Model No25LPA
Baseline Catalog No1002.1526
Baseline IDNA
Baseline Device FamilyELECTROTORQUE PLUS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK934783
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-06-24

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