MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1998-10-15 for BD BABY GLASS THERMOMETER 523906 manufactured by Becton Dickinson.
[15031938]
Grandmother was using thermometer to check baby's temperature rectally. She removed thermometer and noticed tip was not attached. Xrays were taken at hospital but they did not find any part of the thermometer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-1998-00002 |
| MDR Report Key | 195654 |
| Report Source | 04 |
| Date Received | 1998-10-15 |
| Date of Report | 1998-09-18 |
| Date of Event | 1998-09-07 |
| Date Facility Aware | 1998-09-18 |
| Report Date | 1998-10-15 |
| Date Added to Maude | 1998-11-09 |
| 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 | BD BABY GLASS THERMOMETER |
| Generic Name | GLASS THERMOMETER |
| Product Code | FLK |
| Date Received | 1998-10-15 |
| Model Number | NA |
| Catalog Number | 523906 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 190084 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DR. FRANKLIN LAKES NJ 07417 US |
| Baseline Brand Name | BD BABY GLASS THERMOMETER |
| Baseline Generic Name | GLASS THERMOMETER |
| Baseline Model No | NA |
| Baseline Catalog No | 523906 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-10-15 |