MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-25 for BABY THERMOMETER * manufactured by Becton Dickinson (resp. Importer).
[18337862]
Complaint noticed the tip was broken after she removed it from the underarm of her 4 month old who had been crying. Instructions advise users to inspect before using. -complaint thinks there uf the problem is that common.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001819 |
| MDR Report Key | 77806 |
| Date Received | 1997-03-21 |
| Date of Report | 1997-02-25 |
| Date Added to Maude | 1997-03-25 |
| 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 |
| 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 | BABY THERMOMETER |
| Generic Name | BABY THERMOMETER |
| Product Code | FLK |
| Date Received | 1997-03-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | EDR-1534 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 77453 |
| Manufacturer | BECTON DICKINSON (RESP. IMPORTER) |
| Manufacturer Address | 1 BECTON DR FRANKLIN LAKES NJ 07417 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-21 |