FDA Adverse Event Injury Summary report: N

MOONCUP / MCUK

MDR report key: 10706053 · Received October 20, 2020

Report

Report Number
3009117944-2020-00002
Event Type
Injury
Date Received
October 20, 2020
Date of Event
September 23, 2020
Report Date
October 20, 2020
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 VIA EMAIL STATING THAT HAVING USED THE MOONCUP MENSTRUAL CUP CONSISTENTLY FOR TWO YEARS WITH NO ISSUES, THEY DECIDED TO REREAD THE INSTRUCTIONS AND REALISED THAT THEY WERE NOT FOLLOWING THE INSTRUCTIONS EXACTLY. THEY EXPLAIN THAT THEY THEN TRIED TO USE A METHOD DESCRIBED IN THE INSTRUCTIONS (AT THE TIME OF REPORTING IT IS NOT CLEAR WHAT THIS METHOD WAS) WHICH CAUSED IMMEDIATE PAIN AND THE CUSTOMER REPORTS THAT THEY NOW HAVE A PELVIC ORGAN PROLAPSE. THEY REPORT THEY HAVE NO PRE-EXISTING RISK FACTORS FOR PROLAPSE REGARDING AGE AND CHILDBEARING HISTORY AND DESCRIBE THEMSELVES AS OTHERWISE FIT AND HEALTHY. THEY DESCRIBE EXPERIENCING ABDOMINAL PAIN AND LOWER BACK PAIN ALMOST EVERY DAY IN THE MONTHS SINCE THEN. THE CUSTOMER GOES ON TO SAY THAT THEY CANNOT EXERCISE OR BE INTIMATE WITH THEIR PARTNER AND THAT THIS IS CAUSING MANY ONGOING ISSUES. THEY HAVE CONSULTED DOCTORS AND BEEN ADVISED TO DO PELVIC FLOOR EXERCISES WHICH THEY REPORT HAVE NOT TO DATE WORKED. THE CUSTOMER ALSO COMMENTS THAT THEY FEEL THE ONGOING SITUATION WITH COVID-19 HAS IMPACTED ON WHAT MEDICAL CARE IS CURRENTLY AVAILABLE TO THEM. WHILE THE CUSTOMER RESPONDED TO MOONCUP LTD'S INITIAL REPLY, THEY HAVE NOT YET RESPONDED TO FURTHER FOLLOW UP EMAILS AND SO IT HAS NOT SO FAR BEEN POSSIBLE TO INVESTIGATE THIS FURTHER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1167641 MOONCUP / MCUK MENSTRUAL CUP HHE MOONCUP LTD

Patients

Seq Age Sex Outcome Treatment
1 28 YR Other