ASTODIA
Received Jan 29, 2026 · Event occurred Nov 1, 2025
Report 9617473-2026-00001 · MDR key 24208789
Device
Generic name
Transilluminator, Battery-powere
Manufacturer
Stihler Electronic GmbhModel number
DIA120Catalog number
DIA120
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Burn(s)
Narrative
Additional Manufacturer Narrative
NEITHER VISUAL NOR FUNCTIONAL TESTING SHOW ANY DEVIATION FROM THE SPECIFIED DEVICE BEHAVIOR. TEMPERATURE MEASURING DOES NOT SHOW ANY UNEXPECTED VALUES DURING AN USUAL APPLICATION WHICH IS EXPECTED TO LAST LESS THAN 1 MINUTE. GENTHERM MEDICAL, LLC., IS REPRESENTING THE MANUFACTURER AND IS SUBMITTING THIS SUPPLEMENTAL REPORT ON THEIR BEHALF.
Additional Manufacturer Narrative
GENTHERM MEDICAL, LLC., IS REPRESENTING THE MANUFACTURER AND IS SUBMITTING THIS REPORT ON THEIR BEHALF.
Description of Event or Problem
ASTODIA TRANSILLUMINATOR USED FOR PERIPHERAL ARTERIAL LINE PLACEMENT AND RESULTED IN 2 BURNS ON INFANT'S ARM.