TPLC - Total Product Life Cycle

• Device: pessary, vaginal
• Regulation Description: Vaginal pessary.
• Product Code: HHW
• Regulation Number: 884.3575
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CNTRL+ INC.
	SUBSTANTIALLY EQUIVALENT	1
COOPERSURGICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
COSM MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
REIA, LLC
	SUBSTANTIALLY EQUIVALENT	1
RESILIA INC.
	SUBSTANTIALLY EQUIVALENT	1
WATKINS-CONTI PRODUCTS INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	401	401
2021	24	24
2022	14	14
2023	12	12
2024	6	6
2025	34	34

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	187	187
Break	93	93
Component Missing	66	66
Difficult to Remove	46	46
Material Too Rigid or Stiff	43	43
Product Quality Problem	43	43
Difficult to Insert	15	15
Use of Device Problem	9	9
Sharp Edges	9	9
Output Problem	3	3
Material Integrity Problem	3	3
Material Discolored	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Physical Resistance/Sticking	2	2
Patient-Device Incompatibility	2	2
Insufficient Information	2	2
Defective Device	2	2
Patient Device Interaction Problem	2	2
Structural Problem	2	2
Crack	1	1
Material Erosion	1	1
Material Puncture/Hole	1	1
Defective Component	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Microbial Contamination of Device	1	1
Scratched Material	1	1
Material Fragmentation	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Protrusion/Extrusion	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	214	214
No Known Impact Or Consequence To Patient	113	113
No Clinical Signs, Symptoms or Conditions	62	62
Pain	52	52
Discomfort	17	17
Insufficient Information	9	9
Unspecified Infection	7	7
Abnormal Vaginal Discharge	7	7
Genital Bleeding	6	6
Laceration(s)	6	6
Abrasion	6	6
Hemorrhage/Bleeding	5	5
Intermenstrual Bleeding	5	5
Foreign Body In Patient	5	5
Irritation	4	4
Cramp(s) /Muscle Spasm(s)	3	3
Urinary Tract Infection	2	2
Bacterial Infection	2	2
Ulcer	2	2
Unspecified Tissue Injury	2	2
Rectovaginal Fistula	2	2
Injury	2	2
Burning Sensation	2	2
Adhesion(s)	2	2
Hypersensitivity/Allergic reaction	2	2
Abdominal Pain	2	2
Rash	1	1
Fever	1	1
Vaginal Mucosa Damage	1	1
Incontinence	1	1
Swelling	1	1
Urinary Retention	1	1
Cramp(s)	1	1
Blood Loss	1	1
Dyspareunia	1	1
Rupture	1	1
Malaise	1	1
Hematoma	1	1
Anxiety	1	1
Skin Inflammation/ Irritation	1	1
Tissue Damage	1	1
Dysuria	1	1
Fungal Infection	1	1
Urticaria	1	1
Irritability	1	1
Ambulation Difficulties	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	Feb-26-2021
2	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022