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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.
Product CodeHHE
Regulation Number 884.5400
Device Class 2

MDR Year MDR Reports MDR Events
2016 1 1
2017 4 4
2018 1 1
2019 22 22
2020 220 220

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 153 153
Patient Device Interaction Problem 84 84
Adverse Event Without Identified Device or Use Problem 25 25
Suction Problem 8 8
Patient-Device Incompatibility 7 7
Cup 6 6
Break 6 6
Appropriate Term/Code Not Available 5 5
Device Dislodged or Dislocated 3 3
Inadequate Instructions for Non-Healthcare Professional 2 2
Insufficient Information 2 2
Migration or Expulsion of Device 2 2
Entrapment of Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 1 1
Sticking 1 1
Difficult to Fold, Unfold or Collapse 1 1
Leak/Splash 1 1
Product Quality Problem 1 1
Positioning Problem 1 1
Handpiece 1 1
Activation, Positioning or SeparationProblem 1 1
Detachment of Device or Device Component 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 64 64
Therapeutic Effects, Unexpected 44 44
No Known Impact Or Consequence To Patient 43 43
Pain 30 30
Insufficient Information 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Unspecified Infection 9 9
No Code Available 8 8
Fungal Infection 6 6
Prolapse 5 5
Discomfort 5 5
Urinary Tract Infection 5 5
Local Reaction 4 4
Bacterial Infection 4 4
Patient Problem/Medical Problem 4 4
Device Embedded In Tissue or Plaque 4 4
Toxic Shock Syndrome 4 4
Abnormal Vaginal Discharge 3 3
Rash 3 3
Fever 3 3
Hypersensitivity/Allergic reaction 3 3
Irritation 2 2
Skin Irritation 2 2
Swelling 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Nausea 2 2
Abdominal Pain 2 2
Syncope 1 1
Laceration(s) 1 1
Miscarriage 1 1
Diarrhea 1 1
Purulent Discharge 1 1
Ectopic Pregnancy 1 1
Micturition Urgency 1 1
Tachycardia 1 1
Thyroid Problems 1 1
Tissue Damage 1 1
Vomiting 1 1
Weakness 1 1
Burning Sensation 1 1
Not Applicable 1 1
Reaction 1 1
Intermenstrual Bleeding 1 1
Missing Value Reason 1 1
Sexual Dysfunction 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Dysuria 1 1
Thrombosis 1 1
Renal Failure 1 1
Staphylococcus Aureus 1 1
Cramp(s) 1 1
Malaise 1 1
Menstrual Irregularities 1 1
Abortion 1 1
Anemia 1 1
Cyst(s) 1 1
Erythema 1 1

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