inforMED
MalfunctionHEB

U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB

Received Jul 7, 2015 · Event occurred Jun 7, 2015

Report 3011112444-2015-00011 · MDR key 4895522

Device

Generic name

Tampon, Menstrual, Unscented

Model number

SUPER

Lot number

AA434401B2016

Product problems

  • Material Separation
  • Tear, Rip or Hole in Device Packaging
  • Device Operates Differently Than Expected

Patient

39 YR

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

CONSUMER SAID THAT THE STRING TORE AWAY FROM THE COTTON, AND IT BROKE THE TAMPON IN HALF. THERE WAS AROUND HALF OF THE PLEDGET ATTACHED TO THE STRING ON REMOVAL THE PLEDGET SEPARATED LEAVING A PORTION IN THE VAGINAL CANAL.

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.