SERAPH 100
Received May 15, 2025 · Event occurred Apr 24, 2024
Report 3014015528-2025-00009 · MDR key 22023628
Device
Product problems
- Lack of Effect
- Lack of Effect
Patient
NA · Male
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THIS WAS STATED IN THE NYT, SEE (B)(6). "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, (B)(6) 2025. THE MANUFACTURER FOLLOWED UP WITH THE FACILITY IN ANTIGUA WHERE THE CLAIMED ADVERSE EVENTS TOOK PLACE AND WITH THE TREATING PHYSICIAN. THE FACILITY HAS STATED THAT IT WAS NOT AWARE OF ANY ADVERSE EVENTS. THE PHYSICIAN HAS NOT RESPONDED.
Description of Event or Problem
THIS INFORMATION WAS REPORTED PUBLICLY BY THE NEW YORK TIMES. SEE (B)(6). "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, (B)(6) 2025. AS REPORTED IN NYT ARTICLE, PATIENT P2 (IDENTIFIED AS MALE, AGE UNKNOWN, DIAGNOSED WITH COLON CANCER) DIED ON (B)(6), APPROXIMATELY 2 WEEKS AFTER HIS LAST TREATMENT. THE ARTICLE STATES THAT THESE TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN (B)(6).