MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-05-09 for SEA-BOND DENTURE ADHESIVE * manufactured by Combe, Inc..
[332917]
Initial reporter swallowed sea-bond denture adhesive while eating. Pt went to local hospital emergency room reporting pain and nausea. A nasogastric tube was placed. Pt was admitted to hospital for 6 days, during which their eating and bowel functions returned to normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1450238-2002-00001 |
| MDR Report Key | 458912 |
| Report Source | 04 |
| Date Received | 2003-05-09 |
| Date of Report | 2003-04-15 |
| Date of Event | 2002-07-07 |
| Date Facility Aware | 2002-07-15 |
| Report Date | 2003-04-15 |
| Date Mfgr Received | 2002-07-15 |
| Date Added to Maude | 2003-05-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1101 WESTCHESTER AVENUE |
| 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 |
| 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 | 2003-05-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 447874 |
| Manufacturer | COMBE, INC. |
| Manufacturer Address | 1101 WESTCHESTER AVENUE WHITE PLAINS NY 10604 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-05-09 |