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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pessary, vaginal
Regulation Description Vaginal pessary.
Product CodeHHW
Regulation Number 884.3575
Device Class 2


Premarket Reviews
ManufacturerDecision
CNTRL+ INC.
  SUBSTANTIALLY EQUIVALENT 1
COSM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  1.  K231786  Gynethotics™ Pessary
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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 181 181
Break 93 93
Component Missing 66 66
Difficult to Remove 46 46
Material Too Rigid or Stiff 43 43
Product Quality Problem 26 26
Difficult to Insert 15 15
Sharp Edges 9 9
Use of Device Problem 7 7
Output Problem 3 3
Material Integrity Problem 3 3
Material Discolored 3 3
Physical Resistance/Sticking 2 2
Patient-Device Incompatibility 2 2
Insufficient Information 2 2
Defective Device 2 2
Structural Problem 2 2
Adverse Event Without Identified Device or Use 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
Patient Device Interaction Problem 1 1
Material Fragmentation 1 1
Inadequacy of Device Shape and/or Size 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 45 45
Pain 45 45
Discomfort 17 17
Insufficient Information 9 9
Unspecified Infection 7 7
Abnormal Vaginal Discharge 7 7
Laceration(s) 6 6
Genital Bleeding 5 5
Intermenstrual Bleeding 5 5
Abrasion 4 4
Foreign Body In Patient 4 4
Irritation 4 4
Hemorrhage/Bleeding 3 3
Urinary Tract Infection 2 2
Bacterial Infection 2 2
Ulcer 2 2
Injury 2 2
Burning Sensation 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Adhesion(s) 2 2
Hypersensitivity/Allergic reaction 2 2
Abdominal Pain 2 2
Rash 1 1
Fever 1 1
Incontinence 1 1
Swelling 1 1
Cramp(s) 1 1
Blood Loss 1 1
Dyspareunia 1 1
Hematoma 1 1
Skin Inflammation/ Irritation 1 1
Rectovaginal Fistula 1 1
Anxiety 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1
Dysuria 1 1
Fungal Infection 1 1
Urticaria 1 1
Irritability 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
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