MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-08-26 for FEVER THERMOMETER 3303 * manufactured by The First Years.
[135391]
Tip of glass thermometer was broken in case prior to use. Father did not notice and used thermometer rectally on child. Child was taken to emergency room for examination. No evidence of glass or bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217805-1999-00001 |
| MDR Report Key | 237824 |
| Report Source | 04 |
| Date Received | 1999-08-26 |
| Date of Report | 1998-12-08 |
| Date of Event | 1998-12-08 |
| Date Mfgr Received | 1998-12-08 |
| Date Added to Maude | 1999-09-01 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEVER THERMOMETER |
| Generic Name | MERCURY IN GLASS THERMOMETER |
| Product Code | FLK |
| Date Received | 1999-08-26 |
| Model Number | 3303 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 230469 |
| Manufacturer | THE FIRST YEARS |
| Manufacturer Address | ONE KIDDIE DR. AVON MA 02322 US |
| Baseline Brand Name | FEVER THERMOMETER |
| Baseline Generic Name | MERCURY IN GLASS THERMOMETER |
| Baseline Model No | 3303 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-08-26 |