MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-14 for DIGITAL THERMOMETER 3299 * manufactured by The First Years.
[18561605]
The mother is the rptr. The mother was taking a rectal temp of her child and when she wiped the thermometer the tip came off in the cloth. She was very concerned because she felt it could have come off in the child's rectum. She described the tip as being about 3 cm long.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017173 |
| MDR Report Key | 240454 |
| Date Received | 1999-09-14 |
| Date of Report | 1999-09-14 |
| Date of Event | 1999-09-13 |
| Date Added to Maude | 1999-09-20 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| 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 | DIGITAL THERMOMETER |
| Generic Name | DIGITAL THERMOMETER |
| Product Code | FLK |
| Date Received | 1999-09-14 |
| Model Number | 3299 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 232987 |
| Manufacturer | THE FIRST YEARS |
| Manufacturer Address | ONE KIDDIE DR. AVON MA 02322 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-09-14 |