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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device condom
Product CodeHIS
Regulation Number 884.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
CHURCH & DWIGHT CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
CUPID LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL PROTECTION CORP.
  SUBSTANTIALLY EQUIVALENT 2
OKAMOTO U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
RB HEALTH (US) LLC
  SUBSTANTIALLY EQUIVALENT 5
SHANGHAI PERSONAGE HYGIENE PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURETEX LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU COLOUR-WAY NEW MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LTD
  SUBSTANTIALLY EQUIVALENT 1
TITAN CONDOMS LLC
  SUBSTANTIALLY EQUIVALENT 1
TTK HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 15 15
2020 12 12
2021 16 16
2022 18 18
2023 10 10
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 32 32
Adverse Event Without Identified Device or Use Problem 10 10
Material Fragmentation 5 5
Insufficient Information 5 5
Patient-Device Incompatibility 3 3
Device Slipped 3 3
Inadequacy of Device Shape and/or Size 2 2
Defective Component 2 2
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Entrapment of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Emits Odor 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sexually Transmitted Infection 18 18
Insufficient Information 11 11
No Known Impact Or Consequence To Patient 6 6
Foreign Body In Patient 5 5
Hypersensitivity/Allergic reaction 5 5
Rash 5 5
Unspecified Infection 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Viral Infection 3 3
Urinary Tract Infection 2 2
Abnormal Vaginal Discharge 2 2
Burning Sensation 2 2
Abdominal Pain 2 2
Pain 2 2
Aspiration/Inhalation 2 2
Bacterial Infection 2 2
Choking 2 2
Pregnancy with a Contraceptive Device 2 2
Caustic/Chemical Burns 1 1
Device Embedded In Tissue or Plaque 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Death 1 1
Erythema 1 1
Fever 1 1
Herpes 1 1
Peeling 1 1
Pelvic Inflammatory Disease 1 1
Pneumothorax 1 1
Pulmonary Dysfunction 1 1
Pulmonary Insufficiency 1 1
Abrasion 1 1
Airway Obstruction 1 1
Hypoxia 1 1
Hot Flashes/Flushes 1 1
Immunodeficiency 1 1
Dizziness 1 1
HIV, Human Immunodeficiency Virus 1 1
Wheal(s) 1 1
Discomfort 1 1
Irritation 1 1
Itching Sensation 1 1
Respiratory Distress 1 1
Venereal Disease 1 1
Skin Discoloration 1 1
Skin Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
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