MalfunctionEBF
PERMANENT UNIVERSAL TOOTH FILLING COMPOSITE RESIN SELF CURE
Received Oct 22, 2019 · Event occurred Oct 17, 2019
Report MW5090559 · MDR key 9224803
Device
Generic name
Material, Tooth Shade, Resin
Manufacturer
Prime Dental Manufacturing, Inc.Model number
273935071593 EBAYProduct problems
- Expiration Date Error
Patient
41 YR
- Abscess
- Abscess
Narrative
Description of Event or Problem
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).