MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-04-09 for SEA-BOND DENTURE ADHESIVE * manufactured by Combe, Inc..
[610341]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1450238-2007-00001 |
| MDR Report Key | 837732 |
| Report Source | 04 |
| Date Received | 2007-04-09 |
| Date of Report | 2007-04-05 |
| Date Facility Aware | 2007-03-29 |
| Report Date | 2007-04-05 |
| Date Mfgr Received | 2007-03-29 |
| Date Added to Maude | 2007-04-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1101 WESTCHESTER AVE. |
| Manufacturer City | WHITE PLAINS NY 10604 |
| Manufacturer Country | US |
| Manufacturer Postal | 10604 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEA-BOND DENTURE ADHESIVE |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOM |
| Date Received | 2007-04-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 825035 |
| Manufacturer | COMBE, INC. |
| Manufacturer Address | * WHITE PLAINS NY 10604 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-04-09 |