FDA Adverse Event
Injury
Summary report: N
PROFRACTIONAL HANDPIECE
MDR report key: 1612402
·
Received February 16, 2010
Report
- Report Number
- 2953696-2010-00006
- Event Type
- Injury
- Date Received
- February 16, 2010
- Report Date
- July 17, 2008
- Manufacturer
- SCITON, INC.
- Product Code
- GEX
- PMA / PMN Number
- 070388
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
UPON INVESTIGATION BY SCITON STAFF, IT WAS DETERMINED THAT THE CLINICIAN TREATED THE PATIENT WITHOUT DISINFECTING THE PROFRACTIONAL-XC HANDPIECE. THE INSTRUCTIONS IN THE OPERATOR MANUAL REQUIRES THE HANDPIECE TO BE CLEANED AND DISINFECTED PRIOR TO REUSE. NO MALFUNCTION OF THIS DEVICE WAS REPORTED WITH THIS EVENT.
Description of Event or Problem · 1
A CLINICIAN TREATING A PATIENT WITH NON-DISINFECTED PROFRACTIONAL-XC STANDOFF REPORTED THAT THE PATIENT DEVELOPED INFECTION AND REQUIRED HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFRACTIONAL HANDPIECE | 2940 NM LASER | GEX | SCITON, INC. | PROFILE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |