FDA Adverse Event
Injury
Summary report: N
ASTODIA
MDR report key: 24208789
·
Received January 29, 2026
Report
- Report Number
- 9617473-2026-00001
- Event Type
- Injury
- Date Received
- January 29, 2026
- Date of Event
- November 1, 2025
- Report Date
- January 29, 2026
- Manufacturer
- STIHLER ELECTRONIC GMBH
- Product Code
- HJN
- UDI-DI
- 04260114140214
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
GENTHERM MEDICAL, LLC., IS REPRESENTING THE MANUFACTURER AND IS SUBMITTING THIS REPORT ON THEIR BEHALF.
Description of Event or Problem · 0
ASTODIA TRANSILLUMINATOR USED FOR PERIPHERAL ARTERIAL LINE PLACEMENT AND RESULTED IN 2 BURNS ON INFANT'S ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52015 | ASTODIA | TRANSILLUMINATOR, BATTERY-POWERE | HJN | STIHLER ELECTRONIC GMBH | DIA120 | 04260114140214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |