MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-25 for THERMOGRAM manufactured by .
[3292995]
The reporter is a (b)(6), who was recently diagnosed with breast cancer (grade 3 dcsi) and had a lumpectomy. She found out about the cancer a month ago after having mammogram. The last time she had a mammogram was in 2002 because she has been doing her yearly breast screening imaging via thermogram. She is appealing to fda not to acknowledge a thermogram as the best way for breast exam as it does not reveal pre cancerous tissue. Mammogram is far better than thermogram. Mammogram detects precancerous tissue faster than thermogram. Fda please do not approve this device as a screening mechanism for women.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029937 |
| MDR Report Key | 3084769 |
| Date Received | 2013-04-25 |
| Date of Report | 2013-04-25 |
| Date of Event | 2013-04-08 |
| Date Added to Maude | 2013-05-01 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | THERMOGRAM |
| Product Code | LHQ |
| Date Received | 2013-04-25 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-25 |