FDA Adverse Event Injury Summary report: N

MOONCUP®/ MCUK®

MDR report key: 9006516 · Received September 12, 2019

Report

Report Number
3009117944-2019-00003
Event Type
Injury
Date Received
September 12, 2019
Date of Event
August 19, 2019
Report Date
September 13, 2019
Manufacturer
MOONCUP LTD
Product Code
HHE
PMA / PMN Number
K060852
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE CUSTOMER CONTACTED MOONCUP LTD ON (B)(6) 2019 VIA THE SOCIAL MEDIA PLATFORM (B)(6) TO REPORT THAT HAVING PURCHASED A MENSTRUAL CUP 2 YEARS AGO, AND USING IT FOR A FEW MONTHS, THEY WERE EXPERIENCING ISSUES. ON ONE OCCASION THEY HAD DIFFICULTIES REMOVING THE CUP, WERE UNABLE TO BREAK THE SEAL AND THEY WERE ABLE TO FEEL THEIR CERVIX INSIDE THE CUP. IT TOOK SOME TIME TO REMOVE THE CUP AND ON REMOVAL THEY "FELT DIFFERENT INSIDE". THE CUSTOMER REPORTED THAT THEY THEN CALLED A NON-EMERGENCY MEDICAL TELEPHONE LINE AND UPON THEIR ADVICE ATTENDED A HOSPITAL'S ACCIDENT AND EMERGENCY DEPARTMENT. THE CUSTOMER REPORTS THAT THEY "SEEM[ED] TO HAVE SUFFERED SOME SORT OF SMALL PROLAPSE" AND HAVE BEEN UNABLE TO HAVE INTERCOURSE WITH THEIR PARTNER WITHOUT EXTREME PAIN IN THE SUBSEQUENT 2 YEARS. THE CUSTOMER VISITED THEIR GENERAL PRACTITIONER (GP) TO REPORT WHAT HAD HAPPENED. HAVING UNDERGONE A LAPAROSCOPY AS THE GP FELT THE CUSTOMER MAY HAVE ENDOMETRIOSIS, THE RESULTS SHOWED THIS WAS NOT THE CASE. AT THE TIME OF THIS REPORT THE CUSTOMER INFORMS US THAT THEY STILL HAVE NO DIAGNOSIS AND CONTINUE TO EXPERIENCE PAIN DURING INTERCOURSE. THE CUSTOMER HAS SINCE BEEN IN CONTACT VIA EMAIL AND CORRESPONDENCE IS ONGOING. AT THE TIME OF FILING THIS REPORT IT HAS NOT BEEN CONFIRMED THAT THE MENSTRUAL CUP INVOLVED IS A MOONCUP®.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
802228 MOONCUP®/ MCUK® MENSTRUAL CUP HHE MOONCUP LTD

Patients

Seq Age Sex Outcome Treatment
1 Disability