MAUDE Adverse Event Report: XI'AN FURUIZE BIOTECHNOLOGY CO., LTD. JUNE MENSTRUAL CUP; CUP, MENSTRUAL

Device Problems Difficult to Remove (1528); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Prolapse (2475); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 10/13/2020

Event Type  Injury  

Event Description

Suspected uterine prolapse; trouble reaching and removing menstrual cup lead to uterus being pulled.Device included no instructions on removal and depth of cups sitting position did not allow for removal without pulling.Suffering from unusual continued cramping 7 days after start of period and approx 3 days after end.Fda safety report id# (b)(4).

• Brand Name: JUNE MENSTRUAL CUP
• Type of Device: CUP, MENSTRUAL
• Manufacturer (Section D): XI'AN FURUIZE BIOTECHNOLOGY CO., LTD.
• MDR Report Key: 10712212
• MDR Text Key: 212523071
• Report Number: MW5097352
• Device Sequence Number: 1
• Product Code: HHE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 68