FDA Adverse Event
Summary report: N
HIGH FREQUENCY ULTRASOUND DEEP HEATING THERAPY
MDR report key: 21863
·
Received May 19, 1995
Report
- Report Number
- MW4000681
- Date Received
- May 19, 1995
- Report Date
- April 18, 1995
- Manufacturer
- DOCTOR'S INN
- Product Code
- IMG
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
COMPLAINANT IS A BREAST IMPLANT RECIPIENT WITH SILICONE POISONING WHO HAS BEEN RECEIVING TREATMENT FOR THE PAST YEAR FROM A PHYSICIAN WHO CLAIMS TO HAVE FDA APPROVAL TO CONDUCT "HIGH FREQUENCY" ULTRASOUND TREATMENT FOR HER PROBLEM. SHE HAS BEEN GETTING VERY SICK AND HAS UNDERGONE SEVERAL LAB TESTS IN WHICH SHE IS INFORMED THAT SHE HAS THE CLASSIC SIGNS OF LIVER DISORDER. CLAIMANT WANTS TO KNOW IF 1) HIGH FREQUENCY (LEVEL 10) ULTRASOUND CAN CAUSE LIVER DAMAGE; AND 2) THE PHYSICIAN IS APPROVED TO CONDUCT AN EXPERIMENTAL TREATMENT USING HIGH FREQUENCY ULTRASOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIGH FREQUENCY ULTRASOUND DEEP HEATING THERAPY | NA | IMG | DOCTOR'S INN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |