D
Patient 1
PATIENT DEVELOPED 3 SMALL LINEAR BURNS (APPROXIMATELY 5MM - 8MM IN LENGTH) AFTER THE PROCEDURE. PATIENT REQUIRED PRESCRIPTION TOPICAL MEDICATION.
MAUDE MDR 3840665
- MDR report key
- 3840665
- Report number
- 2954354-2013-00017
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-08-12
- Date received
- 2013-08-20
- Adverse event
- 3
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 403
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. RENEE LIERLY, RN
- 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 | MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT | CUTERA, INC. | PBX | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-08-20 | 0 | 1. R |
Event Narratives#
N
Patient 1
DEVICE IS SCHEDULED TO RETURN TO MANUFACTURER FOR EVALUATION.