InjuryHJN
ASTODIA
Received Jan 29, 2026 · Event occurred Nov 20, 2025
Report 9617473-2026-00002 · MDR key 24208877
Device
Product problems
- Patient Device Interaction Problem
Patient
NA · Unknown
- Blister
- Localized Skin Lesion
Narrative
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 INTRAVENOUS PLACEMENT - NURSE NOTED THAT BLISTERS WERE FORMING WHERE THE LIGHT TOUCHED INFANT'S ARM. INFANT HAD BLISTERING AND OPEN WOUNDS.