FDA Adverse Event Malfunction Summary report: N

CORA THE COMFORT FOR TAMPON MULTIPACK 100% COTTON

MDR report key: 22338228 · Received June 25, 2025

Report

Report Number
MW5171943
Event Type
Malfunction
Date Received
June 25, 2025
Date of Event
June 21, 2025
Report Date
June 21, 2025
Manufacturer
CORA D/B/A LYV LIFE
Product Code
HEB
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

WHAT HAPPENED: I PURCHASED A BOX OF CORA ORGANIC COTTON TAMPONS (SUPER ABSORBENCY, BPA-FREE PLASTIC APPLICATOR, TEAL WRAPPER), AND HAD ALREADY USED APPROXIMATELY HALF THE BOX WITHOUT INCIDENT. HOWEVER, WHEN OPENING ANOTHER SEALED TAMPON, I DISCOVERED VISIBLE BLACK SPECKS INSIDE THE PLASTIC APPLICATOR. THE SPECKS APPEAR TO RESEMBLE MOLD OR ANOTHER TYPE OF CONTAMINATION. THIS DISCOVERY WAS EXTREMELY CONCERNING, ESPECIALLY GIVEN THAT I HAD ALREADY USED MULTIPLE TAMPONS FROM THE SAME BOX. PRODUCT NAME: CORA ORGANIC COTTON TAMPONS WITH BPA-FREE PLASTIC APPLICATOR? SUPER ABSORBENCY LOT NUMBER: WP507801F1, DATE OF INCIDENT: (B)(6) 2025, PURCHASE LOCATION: (B)(6). HEALTH EFFECTS: AT THIS TIME, I HAVE NOT EXPERIENCED ANY NOTICEABLE SYMPTOMS, BUT I AM CONCERNED ABOUT POTENTIAL HEALTH RISKS FROM HAVING USED SEVERAL TAMPONS FROM THE SAME CONTAMINATED BOX BEFORE DISCOVERING THE ISSUE. ADDITIONAL NOTES: I HAVE TAKEN A CLEAR PHOTO OF THE AFFECTED TAMPON AND AM WILLING TO PROVIDE IT OR THE REMAINING PRODUCT IF NEEDED FOR INVESTIGATION. I BELIEVE THIS ISSUE WARRANTS IMMEDIATE ATTENTION, AS IT POSES A POTENTIAL RISK TO CONSUMER HEALTH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1238754 CORA THE COMFORT FOR TAMPON MULTIPACK 100% COTTON TAMPON, MENSTRUAL, UNSCENTED HEB CORA D/B/A LYV LIFE WP507801F1

Patients

Seq Age Sex Outcome Treatment
1 22 YR Female