MEDLINE
Received Apr 17, 2026 · Event occurred Mar 23, 2026
Report 1423395-2026-00096 · MDR key 24915515
Device
Product problems
- Material Frayed
- Material Integrity Problem
Patient
6 YR · Female
- Foreign Body In Patient
Narrative
Description of Event or Problem
ACCORDING TO THE FACILITY ON (B)(6) 2026, THE "QTIPS (LISTED IN THE PACK AS COTTON TIP APPLICATOR WERE USED FROM PACK) - NOTED TO HAVE FRAYING FIBERS ON SOME OF THE APPLICATORS.
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY ON (B)(6) 2026, THE "QTIPS (LISTED IN THE PACK AS COTTON TIP APPLICATOR WERE USED FROM PACK) - NOTED TO HAVE FRAYING FIBERS ON SOME OF THE APPLICATORS. SOME WERE WORSE THAN OTHERS, BUT FIBERS WERE COMING OFF OF THE APPLICATOR WHEN USED IN THE SURGICAL SITE (EYE) AND REQUIRING THE SURGEON TO PULL THESE FROM THE SURGICAL SITE. PER THE FACILITY, NO KNOWN HARM OCCURRED BUT POTENTIAL FOR HARM IF THE SURGEON DOESN'T NOTICE THE FIBERS AND DOES NOT REMOVE FROM THE EYE/OTHER SURGICAL SITE. NO FOLLOW-UP CARE WAS NECESSARY PER THE DOCTOR. NO ADDITIONAL INFORMATION AT THIS TIME. 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.