DIVA CUP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-21 for DIVA CUP manufactured by Diva International.

Event Text Entries

[5462637] Pt developed group a streptococcal toxic shock syndrome with group a strep bacteremia on (b)(6) 2015 resulting in 5 day hospitalization. Culture of pt's "divacup" cervical menstruation cap isolated group a strep, likely focus of infection. Pt reports previously following care directions on box. Excerpt from discharge summary below. Hospital course: (b)(6) f with no significant pmhx admitted on (b)(6) 2015 presenting with acute onset abdominal pain, nausea, and diarrhea over night. Pt presented to urgent care, who sent her to ed with concerns of appendicitis. In ed, ct was negative for appendicitis, showed fluid in large and small bowel lumen. Pt was found to have fever to 39. 2 degrees, tachycardia, tachypnea, hypotension, white count of 21. 4 with bandemia, non anion gap metabolic acidosis with respiratory compensation. Ua with 30 protein, 10-14 wbc. Pt had started her period 3 days prior, uses divacup, which had been in for about 18 hours prior to presentation. This was removed upon admission, and hyperemia was noted in the vagina and cervix. No rash, no pharyngitis, no otitis media, no other sites of infection noted. Group a strep toxic shock syndrome: source presumed strep group a vaginitis/cervicitis/endometritis possibly aggravated or affected by the presence of the blood filled menstrual cup filled with group a streptococcal endotoxin. Pt septic on admission. Blood culture positive x1 for group a strep. Cervical cap and vaginal cultures group a and group b strep positive. Pt initially placed on vanc and pcn g, vanc discontinued with speciation of gram + coccit to group a strep. Sepsis resolved, as did abdominal pin and diarrhea on fluids and antibiotics. Discharged after receiving benzathine penicillin 1. 2 mu im. Pt's close contacts to have throat culture for group a strep to check for carrier status. They should be treated to avoid reinfecting pt. Metabolic acidosis: pt with non anion gap metabolic acidosis on admission. Due to gi losses from profuse diarrhea. Resolved with resolution of diarrhea, fluids, and 3 amps bicarbonate. Hypokalemia, hyponatremia: due to gi losses from profuse diarrhea, resolved with resolution of diarrhea. Diarrhea, abdominal pain: due to exotoxin, toxic shock syndrome. Stoll cultures negative, resolved with resolution of toxic shock syndrome. Dates of use: (b)(6) 2015. Diagnosis or reason for use: menstrual period. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5040927
MDR Report Key4551561
Date Received2015-02-21
Date of Report2015-02-21
Date of Event2015-02-15
Date Added to Maude2015-02-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDIVA CUP
Generic NameDIVA CUP
Product CodeHHE
Date Received2015-02-21
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0
ManufacturerDIVA INTERNATIONAL


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2015-02-21

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