inforMED
DeathKOM

SEA-BOND DENTURE ADHESIVE

Received Apr 9, 2007

Report 1450238-2007-00001 · MDR key 837732

Device

Generic name

Denture Adhesive

Manufacturer

Combe, Inc.

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Dislodged
  • Loose
  • Device Slipped

Patient

YR

  • Death
  • Dysphagia/ Odynophagia

Narrative

Description of Event or Problem

INITIAL REPORTER INFORMED MANUFACTURER THAT HIS BROTHER ACCIDENTALLY SWALLOWED SEA BOND DENTURE ADHESIVE AND THEREAFTER, EXPERIENCED DIFFICUTLY SWALLOWING IN GENERAL. MANUFACTURER ATTEMPTED TO CONTACT HIM VIA EMAIL 02/23/2007. 3/29/2007 MANUFACTURER MADE SECOND ATTEMPT TO CONTACT INITIAL REPORTER VIA PHONE AND SPOKE WITH HIS WIFE WHO INFORMED US THAT HER HUSBAND'S BROTHER HAD PASSED AWAY. NO FURTHER INVESTIGATION WAS POSSIBLE AS SHE INDICATED THAT THEY DID NOT WISH TO BE CALLED BACK. SHE WOULD HAVE HER HUSBAND CALL US IF HE CHOSE TO.

Remedial action

  • Other