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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KALTENBACH & VOIGT GMBH PROPHY PEARLS
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KALTENBACH & VOIGT GMBH PROPHY PEARLS Back to Search Results
Device Problems Device Expiration Issue (1216); Device Emits Odor (1425); Failure To Service (1563); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 08/26/2016
Event Type  malfunction  
Event Description
The dental "air polishing" blast media called "prophy pearls" that we had been using with no ill effects was reordered and it came to us with a highly concentrated ammonia odor.We sent that order back to kavo and ordered more.The second order smelled the same way when the container was first opened, so again we did no use it and sent it back.We then ordered the product one more time and again it came in heavy with ammonia.Kavo apparently made no attempts to correct this problem.They once said they would ship from another warehouse and we have not heard or seen anything to indicate that they honored that commitment.We also noticed that the pearls they sent were all expired.A phone call was made to kavo.They had told us that the powder does not expire.If it is true, then why does it have an expiration date on the package? in summary, a series of dental products were shipped to us heavily contaminated with ammonia, which is toxic and if we were not smart enough to reject these products they would have caused harm to our pt population.They have ignored our efforts to communicate the problem.Maybe you can do better.Diagnosis or reason for use: clean plaque off of pt's teeth.
 
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Brand Name
PROPHY PEARLS
Type of Device
PROPHY PEARLS
Manufacturer (Section D)
KALTENBACH & VOIGT GMBH
MDR Report Key6144344
MDR Text Key61540009
Report NumberMW5066482
Device Sequence Number2
Product Code EJR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Dentist
Type of Report Initial
Report Date 11/23/2016
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received12/01/2016
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Type of Device Usage N
Patient Sequence Number1
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