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TPLC
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show TPLC since
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Device
condom, synthetic
Product Code
MOL
Regulation Number
884.5300
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANSELL HEALTHCARE PRODUCTS LLC.
SUBSTANTIALLY EQUIVALENT
1
ANSELL HEALTHCARE PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
1
CHURCH & DWIGHT CO., INC.
SUBSTANTIALLY EQUIVALENT
2
OKAMOTO U.S.A. INC.
SUBSTANTIALLY EQUIVALENT
1
SURETEX LIMITED
SUBSTANTIALLY EQUIVALENT
1
SXWELL USA LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
5
5
2016
4
4
2017
9
9
2018
11
11
2022
2
2
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
7
7
Patient-Device Incompatibility
6
6
Cross Reactivity
4
4
Device Emits Odor
4
4
Material Rupture
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Material Integrity Problem
2
2
Break
2
2
Contamination
1
1
Nonstandard Device
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Unexpected Therapeutic Results
1
1
Split
1
1
Device Markings/Labelling Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Bacterial Infection
6
6
Burning Sensation
5
5
Skin Irritation
4
4
Swelling
3
3
Hypersensitivity/Allergic reaction
3
3
Unspecified Infection
3
3
Irritation
2
2
Venereal Disease
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Infection, Direct
1
1
Urticaria
1
1
Discomfort
1
1
Reaction
1
1
No Patient Involvement
1
1
No Information
1
1
No Code Available
1
1
Pregnancy
1
1
Localized Skin Lesion
1
1
Swelling/ Edema
1
1
Itching Sensation
1
1
Miscarriage
1
1
Muscle Weakness
1
1
Pain
1
1
Scar Tissue
1
1
Urinary Tract Infection
1
1
Abdominal Pain
1
1
Anaphylactic Shock
1
1
Purulent Discharge
1
1
Dyspnea
1
1
Erythema
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Family Dollar Stores, Llc.
II
Aug-17-2022
2
Reckitt Benckiser LLC
II
Mar-09-2019
3
Reckitt Benckiser LLC
II
Oct-10-2018
4
Reckitt Benckiser LLC
II
Sep-24-2018
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