TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CHURCH & DWIGHT CO., INC.
	SUBSTANTIALLY EQUIVALENT	3
CUPID LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GLOBAL PROTECTION CORP.
	SUBSTANTIALLY EQUIVALENT	2
LELO INC.
	SUBSTANTIALLY EQUIVALENT	1
OKAMOTO U.S.A., INC.
	SUBSTANTIALLY EQUIVALENT	1
OKAMOTO USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
RB HEALTH (US) LLC
	SUBSTANTIALLY EQUIVALENT	5
1. K200672 Durex Penck Standard, Durex Penck XL
2. K211152 Durex Condom with Benzocaine
3. K213647 Durex Patronus Wide
4. K220489 Durex Patronus CloseFit, Durex Patronus Regular
5. K222068 Durex Penck III Regular
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

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Family Dollar Stores, Llc.	II	Aug-17-2022