FIRST MODEL OF LOW CERVIX FEMMYCYCLE MENSTRUAL CUP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-05 for FIRST MODEL OF LOW CERVIX FEMMYCYCLE MENSTRUAL CUP manufactured by Femcap.

Event Text Entries

[4955959] I am reporting a problem with a product called the low cervix femmycycle. It is a menstrual cup. I had no urinary or pelvic issues prior to wearing this menstrual cup. I purchased the cup in may and wore it briefly without incident. I used the product again for four hours a few weeks ago. During this time, i had to urinate, which i was supposed to be able to do without removing the menstrual cup from my body. I started to urinate and felt fine, but then, felt a sharp internal pain in my pelvic area. I was not done emptying my bladder, but was unable to pass more urine after this pain. I stood up and lost control of my bladder as the rest of the urine left my body involuntarily. I thought that i was finished urinating and so did not remove the cup. An hour and a half or so later, i went to remove the cup and involuntarily urinated again. I felt a lot of pressure and pain in my pelvic region and back as well as fatigue after this experience. I waited a week thinking that it would heal on its own. I finally went to the doctor and was told not to use the cup again and was given antibiotics and medicine for both a bladder infection and a yeast infection. My urine sample was sent to a lab and tests were negative but my doctor advised me to continue the antibiotics because i may still have had an infection. I am still experiencing some discomfort when my bladder is full. I started to hear about other women getting hurt by this cup and ending up with bladder infection, kidney infections and damage to the cervix. Some of these women contacted the company about their experiences and the company issued a statement about the situation conveying that they did not believe their cup was responsible for people getting hurt. However, the low cervix femmycycle has now been redesigned. I have messaged the company asking both about the redesign and asking for a refund, since i paid full price for this menstrual cup. They are ignoring my messages. This product that hadn't been tested extensively was sent to me without a warning. I would not have chosen to be a tester for an internal device, nor would i have paid full price for it. It is also worth noting that the femmycycle uses suction to work. The instruction booklet that comes with the cup advises users to pull down on the ring at the bottom of the menstrual cup to remove it from the vagina. However, this is very painful as the cup is suctioned inside of the vagina and this seal needs to be broken for removal. The femmycycle cup is also manufactured without air holes to help the user release the suction of the cup upon removal.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5037691
MDR Report Key3999718
Date Received2014-08-05
Date of Report2014-08-04
Date of Event2014-07-18
Date Added to Maude2014-08-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFIRST MODEL OF LOW CERVIX FEMMYCYCLE MENSTRUAL CUP
Generic NameMENSTRUAL CUP
Product CodeHHE
Date Received2014-08-05
Lot Number12MGTA002
Device Sequence No1
Device Event Key0
ManufacturerFEMCAP


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-08-05

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