MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-09 for THE FIRST YEARS COOL ANIMAL TEETHER * manufactured by The First Years.
[19489111]
The problem was that rptr's son had one of the first years teether, the fish to be specific. Rptr's husband noticed that it was leaking and subsequently took it away. Rptr doesn't know how long son had the teether before the problem was discovered. Reported to the first years the problem and they sent me a new teether, the zebra. Rptr never allowed him to use this teether. Rptr recently heard of the recall of the teethers and is quite nervous as to what type of problems can be caused by this bacteria.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037980 |
| MDR Report Key | 682058 |
| Date Received | 2006-02-09 |
| Date of Report | 2006-02-09 |
| Date of Event | 2005-10-15 |
| Date Added to Maude | 2006-03-08 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 YEARS COOL ANIMAL TEETHER |
| Generic Name | TEETHER |
| Product Code | KKO |
| Date Received | 2006-02-09 |
| Returned To Mfg | 2005-11-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 671325 |
| Manufacturer | THE FIRST YEARS |
| Manufacturer Address | * * MA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-09 |