MalfunctionEJJ

TYTIN

Received Jun 8, 2018

Report 1815757-2018-00003 · MDR key 7584018

Device

Generic name

Dental Amalgam Capsule

Manufacturer

Kerr Corporation

Catalog number

29949

Lot number

5-1092

Product problems

Component Missing
Manufacturing, Packaging or Shipping Problem

Patient

Not reported

No Information
No Information

Narrative

Additional Manufacturer Narrative

NO PATIENT INFORMATION IN REGARDS TO AGE, WEIGHT, SEX, ETHNICITY, AND RACE WAS PROVIDED. AN EVALUATION OF THE PRODUCT IS EXPECTED BUT HAS NOT YET BEGUN.

Description of Event or Problem

AN ALLEGED COMPLAINT WAS REPORTED THAT A DOCTOR DISCOVERED SOME CAPSULES HAVE NO MERCURY PILLOW PACK AND SOME CAPSULES HAVE TWO MERCURY PILLOW PACKS OVER SEVERAL YEARS. THE DOCTOR IS CONCERNED ABOUT THE CAPSULES WITH MORE THAN ONE PILLOW PACK AND THE EFFECT THAT IT IS HAVING ON THE PATIENT'S RESTORATIONS.