MalfunctionHEB
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
Received Sep 9, 2015 · Event occurred Aug 17, 2015
Report 3011112444-2015-00017 · MDR key 5065232
Device
Product problems
- Material Fragmentation
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
DEVICE HISTORY RECORD COULD NOT BE REVIEWED A COMPLETE LOT CODE WITH A TIME STAMP 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 UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem
WHEN REMOVING THE TAMPON, THE TAMPON BROKE IN TWO PIECES.