FDA Adverse Event
Death
Summary report: N
SEA-BOND DENTURE ADHESIVE
MDR report key: 837732
·
Received April 9, 2007
Report
- Report Number
- 1450238-2007-00001
- Event Type
- Death
- Date Received
- April 9, 2007
- Report Date
- April 5, 2007
- Manufacturer
- COMBE, INC.
- Product Code
- KOM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEA-BOND DENTURE ADHESIVE | DENTURE ADHESIVE | KOM | COMBE, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |