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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
CHURCH & DWIGHT CO., INC.
  SUBSTANTIALLY EQUIVALENT 3
CUPID LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL PROTECTION CORP.
  SUBSTANTIALLY EQUIVALENT 2
LELO INC.
  SUBSTANTIALLY EQUIVALENT 1
OKAMOTO U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
OKAMOTO USA, 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
  1.  K210294  One Touch Spiral Condom
  2.  K211450  Playboy 3 Contour Condom
TITAN CONDOMS LLC
  SUBSTANTIALLY EQUIVALENT 1
TTK HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 12 12
2021 16 16
2022 18 18
2023 10 10
2024 7 7
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 31 31
Adverse Event Without Identified Device or Use Problem 5 5
Therapeutic or Diagnostic Output Failure 4 4
Device Slipped 3 3
Insufficient Information 3 3
Material Fragmentation 3 3
Patient-Device Incompatibility 2 2
Defective Component 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Split, Cut or Torn 1 1
Entrapment of Device 1 1
Output Problem 1 1
Material Puncture/Hole 1 1
Device Fell 1 1
Difficult to Remove 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Sexually Transmitted Infection 22 22
Insufficient Information 11 11
Rash 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Clinical Signs, Symptoms or Conditions 4 4
No Known Impact Or Consequence To Patient 4 4
Hypersensitivity/Allergic reaction 3 3
Viral Infection 3 3
Pregnancy with a Contraceptive Device 2 2
Foreign Body In Patient 2 2
Urinary Tract Infection 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Venereal Disease 1 1
Dizziness 1 1
Burning Sensation 1 1
Exposure to Body Fluids 1 1
Erythema 1 1
Discomfort 1 1
HIV, Human Immunodeficiency Virus 1 1
Choking 1 1
Immunodeficiency 1 1
Caustic/Chemical Burns 1 1
Bacterial Infection 1 1
Herpes 1 1
Hot Flashes/Flushes 1 1

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