Sample Record for Search: Product Recalls (Medical Devices and Drugs)

MDR REPORT - PRELIMINARY: 3M DENTAL PRODUCTS DIV. 3M STAINLESS STEEL CROWN. SERIOUS INJURY.

FDA Device Classification: (ELZ) CROWN, PREFORMED. 872-3330. 872.3330.
Company: 3M DENTAL PRODUCTS DIV (3M)
FDA Advisory Committee: DENTAL PRODUCTS DEVICE PANEL (DVDEN)
Source: FDA MDR LIST (MDR). LIST EDITION: FEBRUARY 1997
Publication Date: June 25, 1996

THE PT HAD NINE UNITS OF THE SUBJECT DEVICE PLACED IN HER MOUTH ON TEETH B,R,S,T,I,J,K,L, AND M. THE PT LATER DEVELOPED ULCERATIONS IN HER MOUTH AND ECZEMATOUS DIFFUSE DERMATITIS ON HER TRUNK AND EXTREMITIES. THE PT HAD A POSITIVE PATCH TEST FOR AN ALLERGY TO NICKEL. THE PT WAS NOT TESTED FOR ANY OTHER ALLERGIES. THE DERMATOLOGIST SPECULATES THAT THE SUBJECT DEVICE IS CONTRIBUTING TO THE PT'S CONDITION. UPON RECOMMENDATION OF THE DERMATOLOGIST, THE PT'S DENTIST REMOVED THE SUBJECT DEVICE. THE DERMATOLOGIST BELIEVES THAT THE PT HAS PROBLEMS BEYOND AN ALLERGY TO NICKEL THAT EXACERBATE HER CONDITION AND THAT ARE UNRELATED TO THE SUBJECT DEVICE. THE DENTIST WHO PLACED THE SUBJECT DEVICE INDICATED THAT HE HAS PLACED THOUSANDS OF UNITS IN OTHER PTS WITH NO ADVERSE REACTIONS NOTED.

DIOGENES® FDA Regulatory Updates
© 1997 DIOGENES. All rights reserved.
Dialog® File Number 158 Accession Number 855730

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