MalfunctionHEB
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
Received Aug 26, 2015 · Event occurred Jul 29, 2015
Report 3011112444-2015-00016 · MDR key 5031155
Device
Generic name
Tampon, Menstrual, Unscented
Manufacturer
Avent S. De R.l. De C.v.Model number
SUPERLot number
AA505401B2319
Product problems
- Break
Patient
33 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
DEVICE HISTORY RECORD IS UNDER REVIEW. 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
THIS IS A NON US EVENT. CONSUMER STATED THAT A TAMPON FELL APART INSIDE OF HER AS SHE WAS TRYING TO REMOVE IT. PIECES OF COTTON FELL OUT OF HER 2 DAYS LATER.