MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-06 for THE FIRST YEAR STYLE # Y1474 * manufactured by *.
[455740]
Fluid leaked under normal use by pt. Approximately 1-2 tablespoons of liquid ingested. -after incident, learned that product is under recall: see fda recall notice p06-21 dates 02/09/06. Poison control, pediatrician contacted. No adverse reactions 14 hours after event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038439 |
| MDR Report Key | 698943 |
| Date Received | 2006-04-06 |
| Date of Report | 2006-04-06 |
| Date of Event | 2006-04-05 |
| Date Added to Maude | 2006-04-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE FIRST YEAR |
| Generic Name | FLOATING FRIEND TEETHER |
| Product Code | KKO |
| Date Received | 2006-04-06 |
| Model Number | STYLE # Y1474 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 688029 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-06 |