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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
2015 2 2
2016 1 1
2017 4 4
2018 1 1
2019 22 22
2020 97 97

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 85 85
Patient Device Interaction Problem 38 38
Adverse Event Without Identified Device or Use Problem 16 16
Suction Problem 8 8
Patient-Device Incompatibility 6 6
Cup 6 6
Break 5 5
Device Dislodged or Dislocated 3 3
Improper or Incorrect Procedure or Method 2 2
Entrapment of Device 2 2
Migration or Expulsion of Device 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Positioning Problem 1 1
Handpiece 1 1
Material Split, Cut or Torn 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Difficult to Fold, Unfold or Collapse 1 1
Leak/Splash 1 1
Activation, Positioning or SeparationProblem 1 1
Detachment of Device or Device Component 1 1
Fitting Problem 1 1
Microbial Contamination of Device 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 43 43
Therapeutic Effects, Unexpected 35 35
Pain 24 24
Foreign Body In Patient 7 7
Fungal Infection 5 5
No Code Available 5 5
Bacterial Infection 5 5
Unspecified Infection 5 5
Fever 4 4
Toxic Shock Syndrome 4 4
Urinary Tract Infection 4 4
Device Embedded In Tissue or Plaque 4 4
Patient Problem/Medical Problem 4 4
Discomfort 4 4
Rash 3 3
Nausea 3 3
Abdominal Pain 3 3
Diarrhea 2 2
Hypersensitivity/Allergic reaction 2 2
Swelling 2 2
Tachycardia 2 2
Abnormal Vaginal Discharge 2 2
Vomiting 1 1
Weakness 1 1
Cramp(s) 1 1
Thrombosis 1 1
Thyroid Problems 1 1
Tissue Damage 1 1
Syncope 1 1
Renal Failure 1 1
Staphylococcus Aureus 1 1
Sepsis 1 1
Skin Irritation 1 1
Low Blood Pressure/ Hypotension 1 1
Micturition Urgency 1 1
Hyperemia 1 1
Laceration(s) 1 1
Menstrual Irregularities 1 1
Miscarriage 1 1
Purulent Discharge 1 1
Ectopic Pregnancy 1 1
Erythema 1 1
Anemia 1 1
Cyst(s) 1 1
Malaise 1 1
Prolapse 1 1
Increased Respiratory Rate 1 1
Intermenstrual Bleeding 1 1
Dysuria 1 1
Not Applicable 1 1
Test Result 1 1
Missing Value Reason 1 1

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