BIS
Received Jul 18, 2026 · Event occurred Jul 1, 2026
Report 2936999-2026-00286 · MDR key 25865222
Device
Product problems
- Patient Device Interaction Problem
Patient
Not reported
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED SKIN REDNESS AND SWELLING ON THE FOREHEAD AFTER APPROXIMATELY 20 MINUTES OF USE. THE IRRITATED AREA SUBSIDED THE FOLLOWING DAY.
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.