FDA Adverse Event
Injury
Summary report: N
ASTODIA
MDR report key: 23757134
·
Received December 8, 2025
Report
- Report Number
- MW5180151
- Event Type
- Injury
- Date Received
- December 8, 2025
- Date of Event
- November 1, 2025
- Report Date
- December 3, 2025
- Manufacturer
- STIHLER ELECTRONIC GMBH
- Product Code
- HJN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
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 |
|---|---|---|---|---|---|---|---|
| 1990374 | ASTODIA | TRANSILLUMINATOR, BATTERY-POWERED | HJN | STIHLER ELECTRONIC GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DA | Female |