InjuryFTC
DAAVLIN 7 SERIES PHOTOTHERAPY EQUIPMENT
Received Aug 5, 2024 · Event occurred Jul 2, 2024
Report 1526255-2024-00001 · MDR key 19911558
Device
Generic name
7 Series Ct
Manufacturer
The Daavlin Distributing Co.Model number
7 SER CT 311-8100-120V 50/60HZCatalog number
808HO0008CT6
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Prefer Not To Disclose
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
PATIENT DID NOT CONTACT PRESCRIBING DOCTOR FOR DOSING INFORMATION PRIOR TO TREATING WITH NEW EQUIPMENT. PATIENT HAD SEVERE ERYTHEMA WITH BLISTERING AFTER FIRST TREATMENT. PATIENT REQUIRED MEDICAL ATTENTION AND WAS ADMITTED INTO THE HOSPITAL.
Additional Manufacturer Narrative
NO PROBLEM FOUND WITH DEVICE. THIS WAS AN OPERATOR ERROR.