inforMED
MalfunctionKOM

DENTAL ADHESIVE

Received Dec 22, 2002

Report MW1027070 · MDR key 434928

Device

Generic name

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Manufacturer

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Model number

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Catalog number

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Lot number

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Product problems

  • Labelling, Instructions for Use or Training Problem

Patient

64 YR

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

Narrative

Description of Event or Problem

IT HAS DAWNED ON RPTR, AFTER CHANGING DENTAL ADHESIVES FROM FIXODENT TO CVS BRAND, THAT THERE IS NO INDICATION OF THE INGREDIENTS USED IN THE MANUFACTURE OF ANY BRAND OF ADHESIVE. RPTR. BELIEVES THAT SINCE THE PRODUCT IS INGESTED WHEN IT IS WASHED AWAY BY ONE'S OWN SALIVA AND SWALLOWED, THE END USER SHOULD KNOW WHETHER THEY ARE USING SOMETHING THAT MIGHT CONTAIN A SWEETENER OR ANY OTHER ITEM THEY SHOULD AVOID. MOST USERS ARE OF SENIOR STATUS AND CAN HAVE, FOR INSTANCE, DIABETES. THERE COULD BE A DISASTEROUS AFFECT IF THE ADHESIVE WOULD CONTAIN A SUGAR SUBSTANCE. RPTR IS ESPECIALLY CONCERNED BECAUSE THE CVS BRAND HAS SUCH A SWEET TASTE.