• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOONCUP LTD MOONCUP®/MCUK® MENSTRUAL CUP, PRODUCT CODE: HHE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MOONCUP LTD MOONCUP®/MCUK® MENSTRUAL CUP, PRODUCT CODE: HHE Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Cyst(s) (1800); Laceration(s) (1946); Discomfort (2330); No Code Available (3191)
Event Date 03/30/2020
Event Type  Injury  
Event Description

The customer has used a mooncup menstrual cup for 2 and a half years. They contacted mooncup ltd via email to report that during this time they had experienced two bartholin cysts. They report that the first cyst developed after a couple of months of using the menstrual cup, with the second one developing just under two years later. The customer reported that the second cyst had to be operated on. The customer noted that in hindsight the cup would slip to one side causing the end of the cut stem to press to the side of the vagina where both cysts appeared. Removal of the stem did not improve this. The customer initially stopped using the cup during the day as movement was making the discomfort worse, but since experiencing the cysts has decided to stop using the cup. The customer stated that they had never had a bartholin cyst before and their doctor offered no opinion as to the potential cause of these cysts. On asking the customer whether they had any previous gynaecological conditions the customer reported having experienced a mild prolapse after birth of their first child from which they recovered.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMOONCUP®/MCUK®
Type of DeviceMENSTRUAL CUP, PRODUCT CODE: HHE
Manufacturer (Section D)
MOONCUP LTD
vantage point
new england road
brighton, east sussex BN2 7 FE
UK BN2 7FE
Manufacturer (Section G)
MOONCUP LTD
vantage point
new england road
brighton, east sussex BN2 7 FE
UK BN2 7FE
Manufacturer Contact
simon jones
vantage point
new england road
brighton, east sussex BN2 7-FE
UK   BN2 7FE
MDR Report Key9990517
MDR Text Key193364500
Report Number3009117944-2020-00001
Device Sequence Number1
Product Code HHE
Combination Product (Y/N)N
PMA/PMN NumberK060852
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial
Report Date 04/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2020
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/23/2020 Patient Sequence Number: 1
-
-