FDA Adverse Event
Injury
Summary report: N
BLU-U LIGHT TREATMENT
MDR report key: 3695427
·
Received March 19, 2014
Report
- Report Number
- MW5035095
- Event Type
- Injury
- Date Received
- March 19, 2014
- Date of Event
- March 11, 2014
- Report Date
- March 18, 2014
- Manufacturer
- DUSA PHARMACEUTICALS
- Product Code
- MVF
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
HAD TREATMENT FOR ACTINIC KERATOSES, LIGHT THERAPY WAS VERY PAINFUL. SIX DAYS AFTER TREATMENT WAS STILL HAVING EXTREME PAIN. REDNESS AND SWELLING WAS INTENSE. WENT BACK TO DOCTOR, WAS PUT ON ANTIBIOTICS AND PAIN MEDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162685 | BLU-U LIGHT TREATMENT | BLU-U LIGHT TREATMENT | MVF | DUSA PHARMACEUTICALS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other| R |