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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
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
Material Integrity Problem 3 3
Output Problem 3 3
Material Discolored 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Patient-Device Incompatibility 2 2
Defective Device 2 2
Physical Resistance/Sticking 2 2
Insufficient Information 2 2
Structural Problem 2 2
Material Fragmentation 1 1
Material Erosion 1 1
Defective Component 1 1
Material Puncture/Hole 1 1
Patient Device Interaction Problem 1 1
Scratched Material 1 1
Inadequacy of Device Shape and/or Size 1 1
Microbial Contamination of Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Crack 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
Pain 45 45
No Clinical Signs, Symptoms or Conditions 45 45
Discomfort 17 17
Insufficient Information 9 9
Abnormal Vaginal Discharge 7 7
Unspecified Infection 7 7
Laceration(s) 6 6
Genital Bleeding 5 5
Intermenstrual Bleeding 5 5
Foreign Body In Patient 4 4
Abrasion 4 4
Irritation 4 4
Hemorrhage/Bleeding 3 3
Cramp(s) /Muscle Spasm(s) 2 2
Hypersensitivity/Allergic reaction 2 2
Injury 2 2
Abdominal Pain 2 2
Ulcer 2 2
Urinary Tract Infection 2 2
Adhesion(s) 2 2
Bacterial Infection 2 2
Burning Sensation 2 2
Swelling 1 1
Dyspareunia 1 1
Tissue Damage 1 1
Incontinence 1 1
Dysuria 1 1
Fungal Infection 1 1
Rectovaginal Fistula 1 1
Blood Loss 1 1
Cramp(s) 1 1
Rash 1 1
Unspecified Tissue Injury 1 1
Anxiety 1 1
Hematoma 1 1
Fever 1 1
Irritability 1 1
Urticaria 1 1
Skin Inflammation/ Irritation 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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