HUD1421
Received Dec 5, 2025 · Event occurred Nov 8, 2025
Report 1417592-2025-00687 · MDR key 23733179
Device
Product problems
- Crack
- Crack
Patient
21 MO · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPDATE TO H1: AFTER FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE REPORTABLE EVENT TYPE IS A MALFUNCTION. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
CUSTOMER REPORTED CRACKING THE ADAPTOR AFTER USING IT FOR 1 WEEK.
Additional Manufacturer Narrative
CUSTOMER REPORTED CRACKING THE ADAPTOR AFTER USING IT FOR 1 WEEK. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Additional Manufacturer Narrative
UPDATE TO H6. AFTER FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE INVESTIGATION INVOLVED TESTING OF THE ACTUAL/SUSPECTED DEVICE AND TREND ANALYSIS. THE INVESTIGATION FOUND A MATERIAL PROBLEM BUT A CAUSE REMAINS UNESTABLISHED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.