MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for MEDTHERM IRIS manufactured by Meditherm Inc..
[176387428]
Longevity thermography is a company practicing thermography and offering ultrasound in many eastern states, without any kind of business license. The website is very misleading and is causing women to avoid mammograms. Their cameras are not recently calibrated and as such cannot be relied on to accurately perform the scans they say they can. With out dated and uncalibrated equipment this company is a risk to thousands of lives. Please do something. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092408 |
| MDR Report Key | 9621778 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-15 |
| Date Added to Maude | 2020-01-23 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 3 |
| Brand Name | MEDTHERM IRIS |
| Generic Name | SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE) |
| Product Code | LHQ |
| Date Received | 2020-01-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDITHERM INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-22 |