FDA Adverse Event
Malfunction
Summary report: N
TRUSCULPT ID
MDR report key: 15129776
·
Received July 28, 2022
Report
- Report Number
- MW5111168
- Event Type
- Malfunction
- Date Received
- July 28, 2022
- Report Date
- July 26, 2022
- Manufacturer
- CUTERA, INC.
- Product Code
- PBX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PAID (B)(6) FOR TRUSCULPT ID IN (B)(6) 2022. I HAD ZERO RESULTS. TRUSCULPT CUTERA SHOULD BE SHUT DOWN AND BANNED. THEIR PRODUCT IS A SCAM. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 877761 | TRUSCULPT ID | MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT | PBX | CUTERA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female |