MalfunctionHEB
U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB
Received Aug 3, 2015 · Event occurred Jul 6, 2015
Report 3003701733-2015-00011 · MDR key 4959760
Device
Product problems
- Difficult to Remove
- Material Separation
Patient
17 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT CODE WAS NOT PROVIDED BY THE CONSUMER. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem
3 TAMPONS FELL APART INSIDE CONSUMER AS SHE WAS TRYING TO REMOVE THEM . CONSUMER STATED SHE IS OKAY AND SHE GOT ALL THE COTTON PIECES OUT - SHE DID NOT HAVE TO SEE A DOCTOR.