FDA Adverse Event
Other
Summary report: N
PROFILE
MDR report key: 1615607
·
Received February 16, 2010
Report
- Report Number
- 2953696-2010-00010
- Event Type
- Other
- Date Received
- February 16, 2010
- Date of Event
- July 7, 2009
- Report Date
- July 16, 2009
- Manufacturer
- SCITON, INC.
- Product Code
- GEX
- PMA / PMN Number
- 070388
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SCITON CLINICAL STAFF CONCLUDED THAT THE PROBABLE ROUTE CAUSE FOR THIS ADVERSE EVENT WAS MISTAKENLY TREATING FOR HAIR OVER A TATTOO WITH (B)(4). SCITON RECOMMENDS NOT TO TREAT PTS FOR HAIR OVER TATTOOED AREAS. INSTRUCTIONS FOR THIS CONTRAINDICATION ARE PROVIDED IN THE OPERATOR MANUAL FOR THIS DEVICE. THERE IS NO EVIDENCE THAT THERE WAS A DEVICE MALFUNCTION.
Description of Event or Problem · 1
A CLINICIAN PERFORMED A BBLS HAIR REMOVAL TREATMENT ON A (B)(4) TYPE III-IV PT AND REPORTED RECEIVING A CALL FROM A PT WHO REPORTED A WOUND IN THE PREVIOUSLY TATTOOED REGION. THE PT WAS TREATED WITH THE FOLLOWING BBL PROTOCOL PARAMETERS: 640 FILTER, 15 J/CM2, 20MS, 10 DEG C, 1 PASS. THE CLINICIAN DID NOT QUESTION THE FUNCTION OF THE BBLS HANDPIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFILE | BBLS | GEX | SCITON, INC. | PROFILE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |