InjuryFOZ
Saf-T-Intima
Received Jul 27, 2026 · Event occurred Jul 9, 2026
Report 9610847-2026-00304 · MDR key 50022191
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Cellulitis
Narrative
Description of Event or Problem
It was reported that three cases of cellulitis following Saf-T-Intima insertion were reported between July 5 and July 9, all requiring antibiotic therapy. A further investigation is currently ongoing. Based on the information available so far, the events are likely related to user practices rather than a product-related issue. No additional action is required at this stage.
Additional Manufacturer Narrative
H.3. If a device evaluation and/or device history review is completed, a supplemental report will be filed.