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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
  1.  K200672  Durex Penck Standard, Durex Penck XL
  2.  K211152  Durex Condom with Benzocaine
  3.  K213647  Durex Patronus Wide
  4.  K220489  Durex Patronus CloseFit, Durex Patronus Regular
  5.  K222068  Durex Penck III Regular
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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