GENTAL POWER LUX CONTRA ANGLE 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 report with the FDA on 2007-02-15 for GENTAL POWER LUX CONTRA ANGLE 25LPA 1002.1526 manufactured by Kavo America.

Event Text Entries

[20623161] The head of handpiece became hot and burned the pt. The initial burn created a small blister. Ointment was applied to the burn. She healed fine.
Patient Sequence No: 1, Text Type: D, B5


[20820353] The doctor was informed that the handpiece bearings are worn and gritty. A service check was recommended to evaluate if it was time for maintenance repair. In addition, maintenance info was reviewed with the dr.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1419798-2007-00003
MDR Report Key818741
Report Source05
Date Received2007-02-15
Date of Report2007-01-11
Date of Event2006-11-15
Date Mfgr Received2007-01-15
Device Manufacturer Date2005-09-01
Date Added to Maude2007-02-21
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 FDA3
Event Location0
Manufacturer ContactJOHN MILLER, DIR
Manufacturer Street340 E ROUTE 22
Manufacturer CityLAKE ZURICH IL 60047
Manufacturer CountryUS
Manufacturer Postal60047
Manufacturer Phone8473643931
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGENTAL POWER LUX CONTRA ANGLE
Generic Name*
Product CodeEKK
Date Received2007-02-15
Returned To Mfg2007-01-15
Model Number25LPA
Catalog Number1002.1526
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key806225
ManufacturerKAVO AMERICA
Manufacturer Address340 E ROUTE 22 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. Required No Informationntervention 2007-02-15

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