N
Patient 1
THE DEVICE OPERATOR REPORT "ERROR CODES" DURING THE PROCEDURE. THE HANDPIECE HAS RETURNED TO THE MANUFACTURER FOR COMPRESSIVE TESTING. A FOLLOW UP REPORT WILL SUBMITTED AFTER THE ANALYSIS IS COMPLETE.
MAUDE MDR 8538173
- MDR report key
- 8538173
- Report number
- 2954354-2019-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-03-21
- Date received
- 2019-04-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS RENEE LIERLY
- Address
- 3240 BAYSHORE BLVD BRISBANE CA 94005 US
- Phone
- 415-415-4156
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TRUSCULPT ID | MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT | CUTERA, INC | PBX | TRUSCULPT ID | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-04-22 | 0 | 1. O |
Event Narratives#
D
Patient 1
2 LINEAR BLISTERS ON THE TREATMENT AREA (ABDOMEN). THE HANDPIECE ASSOCIATED WITH THE TREATMENT HAS BEEN RETURNED TO CUTERA FOR COMPREHENSIVE TESTING.