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TPLC
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show TPLC since
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2021
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2024
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Device
condom
Product Code
HIS
Regulation Number
884.5300
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
32
32
Adverse Event Without Identified Device or Use Problem
10
10
Insufficient Information
5
5
Material Fragmentation
5
5
Patient-Device Incompatibility
3
3
Device Slipped
3
3
Defective Component
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Fell
1
1
Material Puncture/Hole
1
1
Material Split, Cut or Torn
1
1
Therapeutic or Diagnostic Output Failure
1
1
Difficult to Remove
1
1
Patient Device Interaction Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Detachment of Device or Device Component
1
1
Device Emits Odor
1
1
Labelling, Instructions for Use or Training Problem
1
1
Product Quality Problem
1
1
Output Problem
1
1
Entrapment of Device
1
1
Use of Device Problem
1
1
Device Dislodged or Dislocated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Sexually Transmitted Infection
18
18
Insufficient Information
11
11
Hypersensitivity/Allergic reaction
6
6
Rash
6
6
No Known Impact Or Consequence To Patient
6
6
Foreign Body In Patient
5
5
Unspecified Infection
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Viral Infection
3
3
No Clinical Signs, Symptoms or Conditions
3
3
Urinary Tract Infection
2
2
Bacterial Infection
2
2
Pain
2
2
Choking
2
2
Burning Sensation
2
2
Pregnancy with a Contraceptive Device
2
2
Aspiration/Inhalation
2
2
Abnormal Vaginal Discharge
2
2
Abdominal Pain
2
2
Abrasion
1
1
Skin Discoloration
1
1
Itching Sensation
1
1
Pelvic Inflammatory Disease
1
1
Fever
1
1
Pulmonary Insufficiency
1
1
Burn(s)
1
1
Dizziness
1
1
Irritation
1
1
Venereal Disease
1
1
Discomfort
1
1
Erythema
1
1
Skin Irritation
1
1
Exposure to Body Fluids
1
1
Respiratory Distress
1
1
Pneumothorax
1
1
Peeling
1
1
HIV, Human Immunodeficiency Virus
1
1
Pulmonary Dysfunction
1
1
Hypoxia
1
1
Immunodeficiency
1
1
Caustic/Chemical Burns
1
1
Death
1
1
Wheal(s)
1
1
Hot Flashes/Flushes
1
1
Herpes
1
1
Airway Obstruction
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Family Dollar Stores, Llc.
II
Aug-17-2022
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