MAUDE Adverse Event Report: DIVA INTERNATIONAL INC DIVACUP MENSTRUAL CUP; CUP, MENSTRUAL

Model Number MODEL 2

Device Problem Product Quality Problem (1506)

Patient Problem Bacterial Infection (1735)

Event Date 08/16/2019

Event Type  malfunction  

Event Description

Bacterial infection; i purchased a menstrual cup from (b)(6) last fall that gave me a horrible infection.After doing some shopping tonight, i believe the exact same seller is still distributing fake menstrual cups - and claims to have 1,300-1,500 in storage at their warehouse in (b)(6) - which is unsettling.I worked tirelessly with (b)(6) to get them removed - and yet they just created a new account to continue selling potentially harmless feminine care items.Please see the seller names/account urls below: (b)(6).I'd used a divacup for year prior to this purchase with no problems.Fda safety report id# (b)(4).

• Brand Name: DIVACUP MENSTRUAL CUP
• Type of Device: CUP, MENSTRUAL
• Manufacturer (Section D): DIVA INTERNATIONAL INC
• MDR Report Key: 10028567
• MDR Text Key: 190164028
• Report Number: MW5094394
• Device Sequence Number: 1
• Product Code: HHE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MODEL 2
• Device Catalogue Number: DV002
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 54