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TPLC
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Device
condom
Regulation Description
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
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
Material Fragmentation
3
3
Insufficient Information
3
3
Device Slipped
3
3
Inadequacy of Device Shape and/or Size
2
2
Patient-Device Incompatibility
2
2
Defective Component
2
2
Entrapment of Device
1
1
Device Emits Odor
1
1
Use of Device Problem
1
1
Product Quality Problem
1
1
Detachment of Device or Device Component
1
1
Patient Device Interaction Problem
1
1
Output Problem
1
1
Device Fell
1
1
Material Puncture/Hole
1
1
Difficult to Remove
1
1
Material Split, Cut or Torn
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 Known Impact Or Consequence To Patient
4
4
No Clinical Signs, Symptoms or Conditions
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
Erythema
1
1
Herpes
1
1
Unspecified Infection
1
1
Venereal Disease
1
1
Caustic/Chemical Burns
1
1
Bacterial Infection
1
1
Dizziness
1
1
Hot Flashes/Flushes
1
1
Immunodeficiency
1
1
Abdominal Pain
1
1
Exposure to Body Fluids
1
1
Burning Sensation
1
1
HIV, Human Immunodeficiency Virus
1
1
Discomfort
1
1
Choking
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Family Dollar Stores, Llc.
II
Aug-17-2022
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