ULTRALITE FULL BODY
Received Apr 5, 2006 · Event occurred Feb 27, 2006
Report 1045025-2006-00001 · MDR key 698111
Device
Generic name
Ultralite Dermatological Light
Manufacturer
Ultralite Ent., Inc.Model number
V4824ANBCatalog number
NA
Lot number
NA
Product problems
- Use of Device Problem
Patient
45 YR
- Blister(s)
- Burn(s)
- Pain
- Treatment with medication(s)
Narrative
Description of Event or Problem
A PT RECEIVED TREATMENT AND IT CAUSED PAINFUL SUNBURN. PT WAS TREATED WITH INDOCIN AND ALOE TOPICALLY. NO HOSPITALIZATION REQUIRED. 03-10-06 THE REPORTER STATED TECHNICIAN WOULD BE RETRAINED. UNIT WAS CLEANED BY SARCO CO. 2-24-06 (UNKT USED FOR 3 PATIENTS ON 2-27-06 AND THIS ONE PATIENT ON 3-6-06.
Description of Event or Problem
PT. RECEIVED TREATMENT AND SMALL BLISTER OCCURRED. THE REPORTER STATES UNIT WAS CLEANED BY SARCO CO. 02-24-06. NO LIGHT BULBS CHANGED. HE STATES AFTER CLEANING UNIT DID NOT WORK RIGHT. THE REPORTER STATES TECHNICIAN WILL BE RETRAINED. PT. HAS COMPLETELY HEALED. PT WAS TREATED WITH TOPICAL INOCIN AND ALOE TO PAIN. NO HOSP. REQUIRED.
Description of Event or Problem
PT. RECEIVED TREATMENT AND RESULTED IN PAINFUL SUNBURN. PT TREATED WITH INDOCIN AND ALOE. NO HOSP. REQUIRED. PT HAS RESUMED TREATMENTS ALL IS NORMAL.
Description of Event or Problem
PT. RECEIVED TREATMENT AND RESULTED IN PAINFUL SUNBURN. PT WAS TREATED WITH INDOCIN AND ALOE. NO HOSP. REQUIRED. PT HAS RESUMED TREATMENTS AND ALL IS NORMAL.
Remedial action
- Notification