MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-02-05 for B D ORAL GLASS THERMOMETER 524015 manufactured by Becton Dickinson.
[144441]
Thermometer broke in mouth - cut tongue. Went to emergency room for treatment, dentist also.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-1999-00001 |
| MDR Report Key | 209109 |
| Report Source | 04 |
| Date Received | 1999-02-05 |
| Date of Report | 1999-01-15 |
| Date of Event | 1999-01-01 |
| Date Mfgr Received | 1999-01-15 |
| Date Added to Maude | 1999-02-10 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | B D ORAL GLASS THERMOMETER |
| Generic Name | GLASS THERMOMETER |
| Product Code | FLK |
| Date Received | 1999-02-05 |
| Returned To Mfg | 1999-03-17 |
| Model Number | NA |
| Catalog Number | 524015 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 202935 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US |
| Baseline Brand Name | B D ORAL GLASS THERMOMETER |
| Baseline Generic Name | GLASS THERMOMETER |
| Baseline Model No | NA |
| Baseline Catalog No | 524015 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-02-05 |