SURGICAL HANDPIECE 3555 0.559.0340

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 2008-09-17 for SURGICAL HANDPIECE 3555 0.559.0340 manufactured by Kaltenbach & Voigt Gmbh.

Event Text Entries

[956397] The handpiece burned the patient's lip.
Patient Sequence No: 1, Text Type: D, B5


[8266911] The patient was prescribed hydrocodone and given antibiotics prior to surgery for tooth extraction. Neosporin was given for the burn and the patient was instructed to continue the hydrocodone if the burn on the patient's lip was painful. The doctor's office stated that the patient was doing fine. The office staff was not following proper procedure for maintenance. Proper maintenance was discussed. Bearing were worn and gritty, and falling apart. High debris level was present.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010493-2008-00016
MDR Report Key1163556
Report Source05
Date Received2008-09-17
Date of Report2008-08-20
Date of Event2008-08-15
Date Mfgr Received2008-08-20
Device Manufacturer Date2005-11-09
Date Added to Maude2008-09-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARI LAMBERT, MANAGER,
Manufacturer Street340 EAST MAIN STREET
Manufacturer CityLAKE ZURICH IL 60047
Manufacturer CountryUS
Manufacturer Postal60047
Manufacturer Phone8473643958
Manufacturer G1KALTENBACH & VOIGT GMBH
Manufacturer StreetBISMARCKRING 39
Manufacturer CityBIBERACH D-88400
Manufacturer CountryGM
Manufacturer Postal CodeD-88400
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGICAL HANDPIECE 3555
Generic NameDENTAL HANDPIECE AND ACCESSORIES
Product CodeEKK
Date Received2008-09-17
Returned To Mfg2008-08-20
Model Number3555
Catalog Number0.559.0340
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1192338
ManufacturerKALTENBACH & VOIGT GMBH
Manufacturer AddressBISMARCKRING 39 BIBERACH GM D-88400


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2008-09-17

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