D
Patient 1
COATING FAILURE OF TREATMENT SURFACE ON HANDPIECE. DEVICE OPERATOR USED THE DEVICE TO TREAT SELF. THE COATING FAILURE CAUSED A SMALL BURN THAT HAS HEALED WITHOUT MEDICAL INTERVENTION.
MAUDE MDR 3245112
- MDR report key
- 3245112
- Report number
- 2954354-2013-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-12-14
- Date received
- 2013-01-11
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 403
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS 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 | CUTERA, INC. | PBX | NA | NA | NA | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-01-11 | 0 |
Event Narratives#
N
Patient 1
.