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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
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 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 19 19
Adverse Event Without Identified Device or Use Problem 9 9
Insufficient Information 6 6
Material Rupture 5 5
Cross Reactivity 3 3
Patient-Device Incompatibility 3 3
Material Fragmentation 3 3
Material Integrity Problem 2 2
Entrapment of Device 1 1
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Emits Odor 1 1
Material Puncture/Hole 1 1
Use of Device Problem 1 1
Out-Of-Box Failure 1 1
Device Issue 1 1
Obstruction of Flow 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1

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

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