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

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).

• Brand Name: PERMANENT UNIVERSAL TOOTH FILLING COMPOSITE RESIN SELF CURE
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): PRIME DENTAL MANUFACTURING, INC.
• MDR Report Key: 9224803
• MDR Text Key: 163592467
• Report Number: MW5090559
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/06/2019
• Device Model Number: 273935071593 EBAY
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 95