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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOONCUP LTD MOONCUP® / MCUK®; MENSTRUAL CUP

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MOONCUP LTD MOONCUP® / MCUK®; MENSTRUAL CUP Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Abdominal Pain (1685); Erythema (1840); Fever (1858); Pain (1994); Rash (2033); Staphylococcus Aureus (2058); Swelling (2091); Toxic Shock Syndrome (2108); Weakness (2145)
Event Date 02/27/2012
Event Type  Injury  
Manufacturer Narrative
Toxic shock syndrome literature review.Only two studies to date that mention menstrual cups have both been scientific and carried out in vitro conditions.They looked at the growth of toxic staph aureas on intra-vaginal devices and other materials including various brands of tampons, nasal tampons, polyurethane contraceptive sponge, latex diaphragm and menstrual cups.The materials found to grow the greatest amount of toxic staph aureas were polyacrylates, viscose rayon, gelatin foam, polyester and carboxymethyl cellulose, polyurethane, and smaller amounts in surgical cotton and latex.One of the studies suggested that cotton only tampons did not increase the production of these toxins.Menstrual cups made of elastomeric polymer and nasal tampons made of polymer of polyvinyl acetal were also found to produce no toxins in both studies (1, 2).Nonoxynol-9 which is the spermicidal gel used with diaphragms and contraceptive sponges has also been shown to encourage the growth of staph aureas (2).This is also amplified by the presence of sperm (1) hence increasing the risk of tss when using both these contraceptive devices.There have been at least 4 documented cases of iud related tss, 2 were menstrual, 2 were not and one of which was fatal.One of the non-menstrual women had her iud in situ for 5 years (5, 6, 7, 8).There has been a small association with iud use and tss.A study reviewing iuds which had been removed for bacterial analysis found staph aureas growing on 4% of the devices.This reinforces the view that there is a small risk of staph aureas infection in women using an iud (10).Tss has been linked with ulceration and breaks in the mucus membrane (7) and iuds have also been found to cause microtrauma on the cervix, uterus and vaginal walls (from the strings) which could increase the uptake of bacteria and toxins into the woman's system and in turn increasing the risk of tss (9, 7).There has only been one documented case of fatal tss from an iud.The woman was previously healthy and there were no other possible causes known including menstruation.Her blood test and urine tests were found to be negative.She had no other signs of infection elsewhere in her body.An abdominal and pelvic scan showed no focal infection or abscess.When they removed her iud it grew large amounts of staph aureas and they concluded that the iud was most likely the source of her staph aureas infection (8).Menstrual cups and tss: there appears to be little evidence to support the opinion that using menstrual cups does not increase the risk of tss in women who do not have immunity to the toxic strain of staph aurea.There are limited studies carried out in this area.What we do know is that at the date of this review (05/28/2012) menstrual cups are not mentioned in the united states cdc surveillance analysis and that there have been two scientific studies that have stated that menstrual cups made of elastomeric polymer do not grow toxic staph aureas in vitro conditions (1, 2).The mooncup/mcuk menstrual cup is made of an elastomeric polymer called medical grade silicone (3) which is non-absorbent and apparently inert so should not easily grow bacteria and fungus (1).At mooncup ltd we are cautious when advising women about using our menstrual cups (mooncup and mcuk) and tss.We recommend the following to our customers: we advise that women who have had a previous episode of tss should not use the mooncup/mcuk.We advise that women wash their hands prior to inserting or removing their mooncup/mcuk.We advise women to remove and rinse their mooncup/mcuk at least 4-8 hourly, in accordance with tampon guidelines.We advise that women thoroughly clean their mooncup/mcuk prior to using it for the first time.We advise women of the symptoms of tss in our labelling and to remove their mooncup/mcuk and seek medical help if they experience these symptoms (4).References: tierno p & hanna b.Propensity of tampons and barrier contraceptives to amplify staphylococcus aurea toxic shock syndrome toxin-1.Infect dis in obstet and gynae 1994 (2) pp.140-145.Tierno p ,& hanna b.Ecology of toxic shock syndrome: amplification of toxic shock syndrome toxin-1 by materials of medical interest.Reviews of infectious diseases (11) supplement 1.International symposium on toxic shock syndrome (jan-feb 1989).Pp.S182-s187.Primasil silicones data sheet; pr 415/40 (liquid silicone rubber).Mooncup usage guide 2008.Paris al, herwaldt la, blum d, schmid gp, shands kn, broome cv.Pathologic findings in twelve cases of toxic shock syndrome.Ann intern med 1982; 96 (6 pt 2):852-7.Shands kn, schmid gp, dan bb, et al.Toxic-shock syndrome in menstruating women: association with tampon use and staphylococcus aureus and clinical features in 52 cases.N engl j med 1980; 303: 1436-42.Herzer c (2001) toxic shock syndrome; broadening differential diagnosis.J am board fam med.2001;14(2) 131-136.Klug c, keay r & ginde a (2009) fatal toxic shock syndrome from an intrauterine device, annals of emergency medicine 54, no5, 701-703.Crowder we, shannon fl.Colposcopic diagnosis of vaginal ulcerations in toxic shock syndrome.Obstet gynecol 1983; 63(3 suppl): 50s-53s.Lewis r.A review of bacteriological culture of removed intrauterine contraceptive devices.Br j fam plann 1998; 24(3):95-7.Customer discarded product.
 
Event Description
The customer reported that she inserted her new mooncup menstrual cup for the first time after cleaning it thoroughly as per instructions.On the evening of the second day of using her mooncup, she started to experience a red sunburn type rash, mild abdominal pain, back pain and vaginal pain.She then removed her mooncup and used a sanitary pad.The following morning, she awoke with feelings of weakness, nausea, fever, fainting, swelling and her rash had worsened.The customer reported that following reading the toxic shock symptoms in the mooncup usage guide and due to her experience as a nurse, she realised she had the symptoms of toxic shock syndrome.She was admitted to hospital in shock.Blood tests were performed, urine culture, blood culture and vaginal swab taken and the vaginal swab was found to be positive for staphylococcus aureus.During her admission, her intrauterine contraceptive device (iud) was removed.She was treated with antibiotics and intravenous hydration.She responded to this treatment and after 48 hours in intensive care, she was transferred to the department of infectious diseases for a further 7 days.The customer was diagnosed with toxic shock syndrome.She informed mooncup ltd that she had her intrauterine contraceptive device inserted 4 years previously and had used tampons in the past with no problems.The customer also informed mooncup ltd that her mooncup was not tested for staphylococcus aureas as she had removed this prior to attending the hospital.The mooncup advisors asked the customer for further details of the incident, which she did not provide.Further details required for the investigation were unable to be obtained.The customer had an iud in place alongside the mooncup, however mooncup ltd were unable to establish whether the iud tested positive for staphylococcus aureus, and the mooncup was not sent for bacteriology testing as she had removed it prior to attending the hospital.Therefore no conclusive evidence exists to isolate either device or a combination of the two devices as the direct cause of this event.
 
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Brand Name
MOONCUP® / MCUK®
Type of Device
MENSTRUAL CUP
Manufacturer (Section D)
MOONCUP LTD
vantage point
new england road
brighton, east sussex BN1 4 GW
UK  BN1 4GW
Manufacturer (Section G)
MOONCUP LTD
vantage point
new england road
brighton, east sussex BN1 4 GW
UK   BN1 4GW
Manufacturer Contact
simon boyd-jones
vantage point
new england road
brighton, east sussex BN1 4-GW
UK   BN1 4GW
4412736738
MDR Report Key5626216
MDR Text Key44336726
Report Number3009117944-2016-00001
Device Sequence Number1
Product Code HHE
Combination Product (y/n)N
PMA/PMN Number
K060852
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial
Report Date 03/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 04/03/2012
Initial Date FDA Received05/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age39 YR
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