MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for THERMOGRAPHY manufactured by Unk.
[141252247]
New palpable breast lump, got thermogram (b)(6) 2019 at (b)(6)/ interpreted as low risk with recommendation for 3 month f/u. The pt is now hospitalized with widely metastatic breast cancer. In a (b)(6) y/o woman with a palpable mass in her breast and a positive family history, a mammogram and ultrasound are indicated. This exam result falsely reassured the pt and delayed diagnosis and treatment. Now, there is no cure for her disease. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085624 |
| MDR Report Key | 8487644 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-01-08 |
| Date Added to Maude | 2019-04-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | THERMOGRAPHY |
| Generic Name | SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE) |
| Product Code | LHQ |
| Date Received | 2019-04-04 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-04 |