3M ESPE STAINLESS STEEL CROWN, PRIMARY MOLAR

Description of Event or Problem

ON (B)(6) 2012, IT WAS REPORTED TO 3M ESPE THAT A CHILD WAS HOSPITALIZED AFTER THE CHILD HAD RECEIVED DENTAL TREATMENT, WHICH INCLUDED A 3M(TM) ESPE(TM) PRIMARY STAINLESS STEEL CROWN (MOLAR). THE PLACEMENT OF THE CROWN TOOK PLACE ON (B)(6) 2012. FOLLOWING PLACEMENT OF THE CROWN, THE CHILD DEVELOPED A FEVER AND CHILLS. IN ADDITION, THE PALATE WAS INFLAMED WITH WHITE SPOTS. THE CHILD WAS TAKEN TO A HOSPITAL FOR TREATMENT, DETAILS OF WHICH WERE NOT MADE AVAILABLE TO 3M ESPE. THE TESTS FOR THE CAUSE OF THIS REACTION ARE ONGOING; THE CHILD'S CONDITION IS REPORTED AS RECOVERED.