3M ESPE PENTAMIX LITE AUTOMATIC MIXING UNIT

Additional Manufacturer Narrative

METHOD, RESULTS, CONCLUSIONS: UNFORTUNATELY THE SALES REPRESENTATIVE DID NOT COLLECT THE AFFECTED PRODUCTS AT ONCE AND THE PRODUCTS WEREN'T RETURNED TO 3M ESPE AND THE LOT-NOS ARE NOT KNOWN. THEREFORE NO FURTHER ANALYSIS ON THE PRODUCT OR RETAINED SAMPLE COULD BE DONE. THE IMPRESSION MATERIAL HAS BEEN ASSESSED FOR BIOCOMPATIBILITY AND HAS BEEN FOUND TO BE SAFE FOR ITS INTENDED USE. AS TWO PRODUCTS WERE INVOLVED IN THE ADVERSE EVENT, TWO RECORDS WILL BE SENT TO FDA. THIS REPORT (MANUFACTURER REPORT NUMBER: 9611385-2014-00016) DESCRIBES THE SECOND SUSPECT DEVICE. THE FIRST SUSPECT DEVICE DESCRIPTION IS INCLUDED IN MANUFACTURER REPORT NUMBER 9611385-2014-00015.

Description of Event or Problem

ON (B)(6) 2014 A POTENTIAL ADVERSE EVENT OCCURRED THAT INVOLVED THE 3M ESPE PRODUCTS 3M ESPE PENTAMIX LITE AND 3M ESPE IMPRINT 4 PENTA SUPER QUICK. DURING OPERATION THE MIXING TIP OF THE PENTAMIX MIXING DEVICE CLOGGED AND DETACHED ABRUPTLY. THE IMPRESSION MATERIAL IMPRINT 4 PENTA SUPER QUICK WAS RELEASED UNDER PRESSURE AND THE DENTAL PERSONAL WAS BESPATTERED. NOBODY WAS INJURY. A SALES REPRESENTATIVE OF 3M (B)(4) WAS PRESENT AT THE DOCTOR'S OFFICE DURING THE INCIDENT AND REPORTED THE CASE.