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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KULZER, GMBH TRANSLUX WAVE; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
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KULZER, GMBH TRANSLUX WAVE; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION Back to Search Results
Model Number 66055012
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Although we have not established that the device malfunctioned, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.Because the malfunction allegation could not be confirmed, the cause of the product problem could not yet be determined.
 
Event Description
This occurred in (b)(6).Initial complaint was that translux wave curing light did not function.Upon examination, it became evident that the protective cover on the battery had been unwrapped by the end user.
 
Manufacturer Narrative
This is a follow up report.Manufacturer evaluated returned curing light and determined device may overheat if polarity is reversed by inversion.The device in question showed evidence of being inverted.
 
Event Description
This is a follow up report.Manufacturer evaluated returned curing light and determined device may overheat if polarity is reversed by inversion.The device in question showed evidence of being inverted.
 
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Brand Name
TRANSLUX WAVE
Type of Device
ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
Manufacturer (Section D)
KULZER, GMBH
gruner weg 11
hanau, gm D-634 50
GM  D-63450
Manufacturer (Section G)
KULZER, GMBH
gruner weg 11
hanau, gm D-634 50
GM   D-63450
Manufacturer Contact
rita rogers
4315 south lafayette blvd.
south bend 46614
MDR Report Key6797994
MDR Text Key83213618
Report Number3005665377-2017-00002
Device Sequence Number1
Product Code EBZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K042199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 08/16/2017,07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Model Number66055012
Device Catalogue Number66055012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/16/2017
Distributor Facility Aware Date07/17/2017
Device Age7 MO
Date Report to Manufacturer08/09/2017
Date Manufacturer Received07/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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