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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cup, menstrual
Product CodeHHE
Regulation Number 884.5400
Device Class 2

MDR Year MDR Reports MDR Events
2019 22 22
2020 220 220
2021 40 40
2022 26 26
2023 133 133
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 253 253
Patient Device Interaction Problem 174 174
Adverse Event Without Identified Device or Use Problem 32 32
Insufficient Information 10 10
Patient-Device Incompatibility 10 10
Suction Problem 9 9
Break 8 8
Appropriate Term/Code Not Available 5 5
Compatibility Problem 5 5
Device Dislodged or Dislocated 4 4
Expulsion 4 4
Inadequate Instructions for Non-Healthcare Professional 2 2
Entrapment of Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Migration or Expulsion of Device 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Handling Problem 1 1
Output Problem 1 1
Positioning Problem 1 1
Unintended Movement 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Device Slipped 1 1
Difficult to Fold, Unfold or Collapse 1 1
Leak/Splash 1 1
Fitting Problem 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 176 176
Therapeutic Effects, Unexpected 44 44
No Known Impact Or Consequence To Patient 43 43
Pain 37 37
No Clinical Signs, Symptoms or Conditions 34 34
Insufficient Information 28 28
Urinary Tract Infection 15 15
Unspecified Infection 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
No Code Available 7 7
Prolapse 7 7
Fungal Infection 6 6
Bacterial Infection 6 6
Local Reaction 6 6
Abdominal Pain 5 5
Hypersensitivity/Allergic reaction 5 5
Intermenstrual Bleeding 5 5
Discomfort 5 5
Abnormal Vaginal Discharge 4 4
Unspecified Reproductive System or Breast Problem 4 4
Device Embedded In Tissue or Plaque 4 4
Patient Problem/Medical Problem 4 4
Fever 4 4
Laceration(s) 4 4
Menstrual Irregularities 4 4
Nausea 3 3
Toxic Shock Syndrome 3 3
Rash 2 2
Not Applicable 2 2
Skin Irritation 2 2
Tachycardia 2 2
Anemia 2 2
Hemorrhage/Bleeding 2 2
Irritation 2 2
Cyst(s) 2 2
Diarrhea 1 1
Purulent Discharge 1 1
Dyspnea 1 1
Abortion 1 1
Abscess 1 1
Cervical Changes 1 1
Itching Sensation 1 1
Failure of Implant 1 1
Incontinence 1 1
Micturition Urgency 1 1
Headache 1 1
Thrombosis 1 1
Thyroid Problems 1 1
Tissue Damage 1 1
Renal Failure 1 1
Sepsis 1 1
Septic Shock 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Pneumothorax 1 1
Missing Value Reason 1 1
Neuralgia 1 1
Pleural Empyema 1 1
Unspecified Kidney or Urinary Problem 1 1
Genital Bleeding 1 1
Sexual Dysfunction 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Urinary Incontinence 1 1
Swelling/ Edema 1 1
Malaise 1 1
Reaction 1 1
Dysuria 1 1
Skin Tears 1 1
Vomiting 1 1
Burning Sensation 1 1
Cramp(s) 1 1
Urinary Frequency 1 1
Urticaria 1 1
Distress 1 1

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