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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCLEAN PROPHYLAXIS PASTE; AGENT, POLISHING ABRASIVE, ORAL CAVITY

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ACCLEAN PROPHYLAXIS PASTE; AGENT, POLISHING ABRASIVE, ORAL CAVITY Back to Search Results
Lot Number 0730191
Device Problems Delivered as Unsterile Product (1421); Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The single unit dose cups had holes or perforations in the tops of all.The units in the box, thus making them open and nonsterile.Henry schein, inc.
 
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Brand Name
ACCLEAN PROPHYLAXIS PASTE
Type of Device
AGENT, POLISHING ABRASIVE, ORAL CAVITY
MDR Report Key9295702
MDR Text Key166216280
Report NumberMW5090984
Device Sequence Number1
Product Code EJR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Dentist
Type of Report Initial
Report Date 11/03/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number0730191
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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