MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-11 for THERMOGRAM manufactured by Unk.
[75256534]
Was receiving screening thermograms as a screening for breast cancer under the care of (b)(6) in (b)(6). She was told that this could be used to deflect breast cancer and was told that her thermograms were "negative for cancer". She felt a mass in her breast. There is a 3 cm mass in her breast that is cancer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069732 |
| MDR Report Key | 6566405 |
| Date Received | 2017-05-11 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-05-11 |
| Date Added to Maude | 2017-05-15 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERMOGRAM |
| Generic Name | THERMOGRAM |
| Product Code | ONO |
| Date Received | 2017-05-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2017-05-11 |