N
Patient 1
THE TIP WAS RECEIVED AND VISUALLY INSPECTED. THE TIP DID HAVE BURN MARKS ON THE SIDES OF THE TREATMENT TIP, HOWEVER WE ARE UNABLE TO DETERMINE WHAT CAUSED THE BURN MARKS. THE INVESTIGATION IS ONGOING.
MAUDE MDR 7628983
- MDR report key
- 7628983
- Report number
- 3011423170-2018-00061
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-05-29
- Date received
- 2018-06-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. JULI MOORE
- Address
- 11720 N CREEK PARKWAY N STE 10 BOTHELL WA 98011 US
- Phone
- 636-636-6362
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | THERMAGE TIP | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM | SOLTA MEDICAL, INC. | ONG | MC-TIP-RP-4S | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-06-22 | 0 |
Event Narratives#
D
Patient 1
AT THE BEGINNING OF A FRAXEL TREATMENT TO THE FACE A SPARK EMITTED FROM THE TIP. THE PATIENT WAS NOT INJURED.