MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-05 for TEM/COM (DISTRIBUTED BY O/METER) * manufactured by Tem Com.
[20890970]
Tem-com mercury thermometer broken off in infants rectum. Thermometer appeared normal prior to insertion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020994 |
| MDR Report Key | 314928 |
| Date Received | 2001-02-05 |
| Date of Report | 2001-01-29 |
| Date of Event | 2001-01-28 |
| Date Added to Maude | 2001-02-08 |
| 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 | TEM/COM (DISTRIBUTED BY O/METER) |
| Generic Name | MERCURY THERMOMETER |
| Product Code | FLK |
| Date Received | 2001-02-05 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 304567 |
| Manufacturer | TEM COM |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-02-05 |