MalfunctionHEB
U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
Received Aug 10, 2015 · Event occurred Jul 13, 2015
Report 3011112444-2015-00013 · MDR key 4988057
Device
Product problems
- Material Discolored
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 RETURNED COMPLAINT SAMPLE FOR EVALUATION WHICH TESTING OF PRODUCT IDENTIFIED MOLD.
Description of Event or Problem
CONSUMER FOUND A LARGER BLACK SPOT ON LAST TAMPON IN THE PACKAGE. THE SPOT LOOKED LIKE MOLD TO HER.