inforMED
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

Model number

SUPER

Lot 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.