MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1998-04-10 for B D ORAL GLASS THERMOMETER UNK manufactured by Becton Dickinson.
[153789]
Customer claims thermometer broke in 9 year old's mouth. She took child to emergency room. Doctor did not find any injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-1998-00001 |
| MDR Report Key | 195658 |
| Report Source | 04 |
| Date Received | 1998-04-10 |
| Date of Report | 1998-04-08 |
| Date of Event | 1998-03-01 |
| Date Facility Aware | 1998-04-03 |
| Report Date | 1998-04-08 |
| Date Mfgr Received | 1998-04-03 |
| 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 | B D ORAL GLASS THERMOMETER |
| Generic Name | GLASS THERMOMETER |
| Product Code | FLK |
| Date Received | 1998-04-10 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 190087 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DR. FRANKLIN LAKES NJ 07417 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-04-10 |