GENTLEPOWER LUX CONTRA ANGLE 25LPA 1.002.1526

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 2007-04-12 for GENTLEPOWER LUX CONTRA ANGLE 25LPA 1.002.1526 manufactured by Kavo America.

Event Text Entries

[558293] The handpiece became hot and burned the patient lip. Ointment was applied to the burn.
Patient Sequence No: 1, Text Type: D, B5


[7818206] Head is damaged due to dent at back end cap. Bearing and gears are worn. Gritty in drive assembly. Shaft and axle have heavy debris. Maintenance information was reviewed with the office and maintenance sheets were sent.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1419798-2007-00015
MDR Report Key839563
Report Source05
Date Received2007-04-12
Date of Report2007-04-11
Date of Event2007-03-26
Date Mfgr Received2007-03-27
Device Manufacturer Date2006-04-01
Date Added to Maude2007-04-23
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 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 NameGENTLEPOWER LUX CONTRA ANGLE 25LPA
Generic NameOPERATIVE DENTAL UNIT ACCESSORY
Product CodeEKK
Date Received2007-04-12
Returned To Mfg2007-03-28
Model Number25LPA
Catalog Number1.002.1526
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key826851
ManufacturerKAVO AMERICA
Manufacturer Address340 E ROUTE 22 LAKE ZURICH IL 60047 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2007-04-12

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