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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
ANSELL HEALTHCARE PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHURCH & DWIGHT CO., INC
  SUBSTANTIALLY EQUIVALENT 1
CHURCH & DWIGHT CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
CHURCH & DWIGHT CO.,INC.
  SUBSTANTIALLY EQUIVALENT 1
CUPID LIMITED
  SUBSTANTIALLY EQUIVALENT 1
  1.  K201067  CUPID Brand Male Natural Rubber Latex Condoms (Pla ...
GLOBAL MAILER PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL PROTECTION CORP.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU DAMING UNITED RUBBER PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
LELO INC.
  SUBSTANTIALLY EQUIVALENT 2
M3 GLOBAL ENTERPRISES, LLC
  SUBSTANTIALLY EQUIVALENT 1
OKAMOTO U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
RB HEALTH (US) LLC
  SUBSTANTIALLY EQUIVALENT 1
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 3
THAI NIPPON RUBBER INDUSTRY PUBLIC COMPANY LTD
  SUBSTANTIALLY EQUIVALENT 1
TTK HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG XIANGBAN LATEX PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 5 5
2017 8 8
2018 11 11
2019 15 15
2020 12 12
2021 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Break 21 21
Adverse Event Without Identified Device or Use Problem 9 9
Insufficient Information 6 6
Material Rupture 5 5
Material Fragmentation 3 3
Patient-Device Incompatibility 3 3
Cross Reactivity 3 3
Material Integrity Problem 2 2
Entrapment of Device 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 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
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Out-Of-Box Failure 1 1
Device Issue 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
Venereal Disease 5 5
Foreign Body In Patient 5 5
Hypersensitivity/Allergic reaction 5 5
Unspecified Infection 4 4
Pain 4 4
Sexually Transmitted Infection 4 4
Insufficient Information 4 4
Reaction 4 4
Skin Discoloration 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Rash 3 3
Peeling 2 2
Urinary Tract Infection 2 2
Abnormal Vaginal Discharge 2 2
Itching Sensation 2 2
Hypoxia 2 2
Abdominal Pain 2 2
Aspiration/Inhalation 2 2
Bacterial Infection 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Skin Irritation 2 2
Viral Infection 2 2
Herpes 2 2
Injury 2 2
Choking 2 2
Pregnancy 2 2
Pregnancy with a Contraceptive Device 2 2
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
No Code Available 1 1
Discomfort 1 1
Swelling 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Death 1 1
Ectopic Pregnancy 1 1
Edema 1 1
Erythema 1 1
Fever 1 1
Gangrene 1 1
Hemorrhage/Bleeding 1 1
Abrasion 1 1
Airway Obstruction 1 1
Miscarriage 1 1
Undesired Nerve Stimulation 1 1
Irritation 1 1
Burning Sensation 1 1
Hot Flashes/Flushes 1 1
Cramp(s) 1 1
Dizziness 1 1
HIV, Human Immunodeficiency Virus 1 1
Wheal(s) 1 1
Pelvic Inflammatory Disease 1 1
Pneumothorax 1 1
Pulmonary Dysfunction 1 1
Pulmonary Insufficiency 1 1
Local Reaction 1 1
Respiratory Distress 1 1
Scarring 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Reckitt Benckiser LLC II Feb-23-2017
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