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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cup, menstrual
Regulation Description Menstrual cup.
Definition A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
Product CodeHHE
Regulation Number 884.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
MENSTRUAL MATES
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 40 40
2022 26 27
2023 133 133
2024 29 29
2025 35 35
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 143 143
Difficult to Remove 140 140
Insufficient Information 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Device-Device Incompatibility 7 7
Compatibility Problem 5 5
Patient-Device Incompatibility 5 5
Expulsion 4 4
Break 4 4
Device Dislodged or Dislocated 2 2
Device Slipped 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 2
Suction Failure 1 1
Unintended Movement 1 1
Use of Device Problem 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Suction Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 119 119
No Clinical Signs, Symptoms or Conditions 55 55
Pain 35 36
Urinary Tract Infection 11 11
Discomfort 8 8
Insufficient Information 7 7
Abdominal Pain 6 6
Hypersensitivity/Allergic reaction 5 5
Laceration(s) 5 5
Unspecified Infection 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Genital Bleeding 4 4
Unspecified Reproductive System or Breast Problem 4 4
Intermenstrual Bleeding 4 4
Swelling/ Edema 3 3
Menstrual Irregularities 3 3
Itching Sensation 3 3
Hemorrhage/Bleeding 2 2
Nausea 2 2
Local Reaction 2 2
Burning Sensation 2 2
Inflammation 2 2
Fever 2 2
Bacterial Infection 2 2
Prolapse 2 2
Skin Tears 1 1
Abnormal Vaginal Discharge 1 1
Not Applicable 1 1
Syncope/Fainting 1 1
Neuralgia 1 1
Pleural Empyema 1 1
Unspecified Kidney or Urinary Problem 1 1
Urinary Incontinence 1 1
Cervical Changes 1 1
Cyst(s) 1 1
Dyspnea 1 1
Ecchymosis 1 1
Abrasion 1 1
Abscess 1 1
Anemia 1 1
Headache 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Incontinence 1 1
Urinary Frequency 1 1
Urticaria 1 1
Distress 1 1
Sepsis 1 1
Septic Shock 1 1
Tachycardia 1 1

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