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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIVA INTERNATIONAL INC. THE DIVACUP MODEL 2 MENSTRUAL CUP

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DIVA INTERNATIONAL INC. THE DIVACUP MODEL 2 MENSTRUAL CUP Back to Search Results
Model Number MODEL 2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Anemia (1706); Diarrhea (1811); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Renal Failure (2041); Tachycardia (2095); Thrombosis (2100); Thyroid Problems (2102); Toxic Shock Syndrome (2108); Vomiting (2144)
Event Date 03/21/2019
Event Type  Injury  
Manufacturer Narrative

Timeline of investigation: diva international was made aware of the incident as a result of a complaint reported to health (b)(6) by the complainant (initial reporter), (b)(6), on (b)(6) 2019. Ms. (b)(6) is a medical resident student that saw the patient ((b)(6)) during training rounds at the hospital. Health (b)(6) contacted diva international on april 24, 2019, at which time diva international became aware of the incident and initiated its investigation into the event. Diva international immediately began a review of all consumer complaints and feedback received from january 2019 to present to determine if any reports of symptoms similar to what the patient experienced (including severe abdominal pain, fever, nausea and vomiting, diarrhea and skin rash) been received. No such reports were identified. Diva international reached out to ms. (b)(6) on april 24 to request further information regarding the incident. Communication with ms. (b)(6) between april 28 to april 30, 2019 clarified details of the incident. Requests for patient contact information and details necessary to access the patient's medical records were requested from ms. (b)(6) on april 30, 2019. Follow up requests were made on may 3, may 9 and may 23, after no response was received to our initial request. A response was received from ms. (b)(6) on may 24, 2019 with the requested patient information. Diva international reached out to the patient ((b)(6)) on may 29, 2019 to gather further information on her experience, usage, care and handling of the divacup, as well as written consent to access her medical records from the hospital. (b)(6) provided written consent to access her medical report on may 29, 2019 and this was forwarded to the hospital on may 31, 2019. Follow up with the hospital's medical record archives was made on june 7 and (b)(6)'s medical records were delivered to diva international inc. On june 14, 2019. At this time, diva international was able to confirm the toxic shock syndrome (tss) diagnosis (gynecologically based). Corrective actions: during the investigation, diva international reviewed the current toxic shock syndrome (tss) precautions described in the divacup user guide: "we recommend that you consult with your physician prior to using the divacup if you have been previously diagnosed with tss (toxic shock syndrome). Discontinue use of the divacup and contact your health practitioner if you experience any of the following symptoms: sudden vomiting, diarrhea, high fever, headache, sun-burn like rash, muscle aches, confusion or seizures. " while the current user guide advises appropriate precautions, discontinued use and medical attention in the event of tss symptoms, diva international has added to the tss precautionary statements to provide greater clarity of the risk associated with all internally worn menstrual care products: "toxic shock syndrome (tss) is a rare, but serious disease caused by toxin-producing strains of the staphylococcus aureus bacterium. In extremely rare cases, the strain may present itself with infection linked to the use of internal menstrual care products. We recommend that you consult your physician prior to using the divacup if you have been previously diagnosed with tss (toxic shock syndrome). Discontinue use of the divacup and contact your health practitioner if you experience any of the following symptoms: sudden vomiting, diarrhea, high fever, headache, sunburn-like rash, muscle aches, confusion or seizures. " the updated precautionary statements also complement the current tss advisory posted on www. Divacup. Com: "toxic shock syndrome (tss) is a rare, but serious disease caused by toxin-producing strains of the staphylococcus aureus bacterium. In extremely rare cases, the strain may present itself with infection linked to the use of internal menstrual care products or as a result of surgery or burns. When exposed to the strain, tss may affect a small number of people (including men, women and children). As we are not medically staffed, we recommend talking to your doctor with regards to any gynecological/medical concerns or conditions. Our user guide and website include detailed instructions for use and maintenance, and it is important to use the divacup pursuant to these directions. Use caution to thoroughly wash your hands prior to insertion and removal and wash the cup with warm water and the divawash at least 2-3 times a day (every 10-12 hours). It is also recommended that you boil your divacup in between cycles. We recommend that you consult your physician prior to using the divacup if you have been previously diagnosed with tss (toxic shock syndrome). Discontinue use of the divacup and contact your health practitioner if you experience any of the following symptoms: sudden vomiting, diarrhea, high fever, headache, sunburn-like rash, muscle aches, confusion or seizures. ".

 
Event Description

As reported by the initial reporter of the event to health (b)(6) ((b)(6) 2019) and confirmed by (b)(6) (may 29, 2019): (b)(6) began experiencing symptoms (fever) on (b)(6) 2019 towards the end of her menstrual cycle. The patient continued to wear the divacup (model 2), emptying and cleaning the device every 6 hours. The patient removed the divacup the following day on (b)(6) 2019 (around 2pm) at the end of her menstrual cycle (she had worn the cup for 7 days, emptying and cleaning every 6 hours). At this time, the patient reported slight stomach pain, her abdomen was pink and hard, and continuing fever. The patient subsequently experienced vomiting, diarrhea and high fever. The patient called an ambulance on (b)(6) 2019 and was subsequently admitted to the hospital and diagnosed with toxic shock syndrome (tss). Antibiotics were started early and she was admitted to critical care in critical condition requiring intravenous fluid resuscitation, 3 simultaneous vasopressor agents and endotracheal intubation. The initial examination showed significant abdominal pain as well as pain in the cervix and appendages. Computed tomography revealed signs of pelvic infection. As the antibiotics administered proved insufficient to control the infection, the patient had to undergo a hysterectomy and bilateral salpingo-oophorectomy. The uterus and the uterine tubes were described as "purulent," but were not cultivated for confirmation of tss. Kidney failure associated with the infection gradually deteriorated and the patient became anuric, requiring renal replacement therapy, initially continuous venovenous hemodiafiltration followed by hemodialysis for 2-3 weeks. This reported event was the first time (b)(6) saw a healthcare professional regarding use of the divacup. (b)(6) reported no prior pain, discomfort, odor, etc. When using the divacup. (b)(6) had been using the model 1 divacup for several years before switching to the model 2 divacup in (b)(6) 2019, due to occasional leaks. She followed the recommendations in the user guide, boiling the divacup after purchase (i. E. Before first use) and between menstrual cycles, and stored the cup in its fabric bag when not in use. (b)(6) reported being very satisfied with the divacup. She never experienced any problems, the cup was in good condition (no odor) and she was able to insert and remove the cup without difficulty. She used the model 2 divacup for 3 menstrual cycles ((b)(6) to (b)(6) 2019). She wore the divacup for 7 days, removing it to empty and clean every 6 hours using dove bar soap or liquid (b)(6) soap. Symptoms began at the end of her menstrual cycle on (b)(6) 2019 and she called an ambulance on (b)(6) 2019. (b)(6) experienced symptoms for 3-4 days before calling an ambulance. She reported not immediately making the connection with the divacup and thought "it was a virus". (b)(6) provided written consent to access her medical report, on may 29, 2019. Additional information included within (b)(6)'s medical report (obtained june 14, 2019): date of admittance: (b)(6) 2019; date of departure: (b)(6) 2019; length of stay 25 days. Primary diagnosis: septic shock with probable toxic component from gynecology. The hysterectomy and bilateral salpingo-oophorectomy was performed (b)(6) 2019. (b)(6) remained in intensive care with endotracheal intubation from (b)(6) 2019. (b)(6) presented with acute tubular necrosis and required renal replacement therapy (continuous venovenous hemodiafiltration, sled, followed by hemodialysis) was performed (b)(6) - (b)(6) 2019. Last hemodialysis was performed on (b)(6) and catheter was removed (b)(6) 2019. Antibiotic therapy: (b)(6) was initially given clindamycin and tazocin ((b)(6) 2019), tazocin only ((b)(6) - (b)(6) 2019), meropenem ((b)(6) 2019), fluconazole ((b)(6)), cipro + flagyl ((b)(6)). (b)(6) presented with mixed multifactorial anemia and received 3 transfusions during her hospitalization (in the context of the other complications such as tachycardia and renal failure). (b)(6) presented with febrile episodes without a definitive cause and was diagnosed with pelvic thrombosis. (b)(6) received intravenous heparin treatment for 8 days upon which her temperature normalized. (b)(6) was without fever for more than 72 hours at departure. (b)(6) developed subclinical hypothyroidism and was prescribed synthroid with recommendation to wean dosage in two months. Follow up was scheduled at departure. (b)(6) was released from the hospital on (b)(6) 2019 in a stable stare with a clear clinical improvement. Follow up with her attending gynecologist was scheduled for 6 weeks from departure.

 
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Brand NameTHE DIVACUP MODEL 2
Type of DeviceMENSTRUAL CUP
Manufacturer (Section D)
DIVA INTERNATIONAL INC.
222 mcintyre drive
kitchener, N2R 1 E8
CA N2R 1E8
Manufacturer (Section G)
DIVA INTERNATIONAL INC.
222 mcintyre drive
kitchener, N2R 1 E8
CA N2R 1E8
Manufacturer Contact
amanda ramnarine
222 mcintyre drive
kitchener, ontario N2R 1-E8
CA   N2R 1E8
MDR Report Key8731663
MDR Text Key149244649
Report Number3005113602-2019-00001
Device Sequence Number1
Product Code HHE
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK021356
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Other
Type of Report Initial
Report Date 06/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMODEL 2
Device Catalogue NumberDV002
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2019
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 TREATMENT DATA
Date Received: 06/25/2019 Patient Sequence Number: 1
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