MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-15 for FAICHNEY UNK manufactured by Faichney Med Co.
[40325]
Consumer reported that the thermometer broke while in her daughter's mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1933255-1997-00001 |
| MDR Report Key | 63259 |
| Date Received | 1997-01-15 |
| Date of Report | 1997-01-15 |
| Date of Event | 1997-01-06 |
| Date Facility Aware | 1997-01-06 |
| Report Date | 1997-01-15 |
| Date Reported to FDA | 1997-01-15 |
| Date Reported to Mfgr | 1997-01-16 |
| Date Added to Maude | 1997-01-22 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FAICHNEY |
| Generic Name | ORAL THERMOMETER |
| Product Code | FLK |
| Date Received | 1997-01-15 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 63440 |
| Manufacturer | FAICHNEY MED CO |
| Manufacturer Address | 17159 SURREY VIEW DR CHESTERFIELD MO 63005 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-15 |