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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIME DENTAL MANUFACTURING, INC. PERMANENT UNIVERSAL TOOTH FILLING COMPOSITE RESIN SELF CURE MATERIAL, TOOTH SHADE, RESIN

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PRIME DENTAL MANUFACTURING, INC. PERMANENT UNIVERSAL TOOTH FILLING COMPOSITE RESIN SELF CURE MATERIAL, TOOTH SHADE, RESIN Back to Search Results
Model Number 273935071593 EBAY
Device Problem Expiration Date Error (2528)
Patient Problem Abscess (1690)
Event Date 10/17/2019
Event Type  malfunction  
Event Description
I purchased a product tooth filing (resin) from ebay the seller name is tbqualityproducts(953), name (b)(6), it's packing product at home. I guess the product don't come in box with any expiration date, just use zip bag and print expiration date with price gun. It's harmful, i had abscess after use it until i get medical treatment. Fda safety report id# (b)(4).
 
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Brand NamePERMANENT UNIVERSAL TOOTH FILLING COMPOSITE RESIN SELF CURE
Type of DeviceMATERIAL, TOOTH SHADE, RESIN
Manufacturer (Section D)
PRIME DENTAL MANUFACTURING, INC.
MDR Report Key9224803
MDR Text Key163592467
Report NumberMW5090559
Device Sequence Number1
Product Code EBF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/06/2019
Device Model Number273935071593 EBAY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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