inforMED
OtherKOQ

ORAFIX SPECIAL DEN. ADHESIVE

Received Oct 30, 1997 · Event occurred Jun 1, 1997

Report MW1012429 · MDR key 130354

Device

Generic name

*

Model number

*

Catalog number

*

Lot number

70313

Product problems

  • Pitted
  • Inadequate Service

Patient

61 YR

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

RPTR TELEPHONED SMITHKLINE BEECHAM, AND WAS INFORMED THAT THIS PRODUCT WAS SOLD TO HOGIL PHARMACEUTICAL CORP. ON APRIL 1, 1996 AND THAT THEY WERE NOW THE MFR. THE RPTR HAS 2 QUESTIONS. WHO MANUFACTURES THIS PRODUCT? WHAT ARE THE INGREDIENTS?