U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB
Received Jul 20, 2015 · Event occurred Jun 24, 2015
Report 3011112444-2015-00012 · MDR key 4925171
Device
Generic name
Tampon, Menstrual, Unscented
Manufacturer
Avent S. De R.l. De C.v.Model number
REGULARLot number
AA501701B
Product problems
- Break
- Component Falling
Patient
21 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CONSUMER COMPLAINED OF PLEDGET BREAKING INSIDE OF HER DURING REMOVAL. SHE STATES THAT THIS ONLY HAPPENED WITH 1 TAMPON AND WHEN SHE WENT TO REMOVE IT THE PRODUCT BROKE INSIDE OF HER. SHE DID HAVE TO MANUALLY REMOVE THE PRODUCT. SHE WAS ABLE TO REMOVE THE PRODUCT WITH NO DOCTOR. SHE IS FINE NOW WITH NO SYMPTOMS.
Additional Manufacturer Narrative
DEVICE HISTORY RECORD IS UNDER REVIEW. A VISUAL INSPECTION OF 4 COMPANION SAMPLES WAS CONDUCTED. THE VISUAL EXAMINATION DID NOT OBSERVE ANY PRODUCT DEFECTS OR ABNORMALITIES. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.