TPLC - Total Product Life Cycle

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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

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