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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
CONTIPI LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONTIPI MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
COSM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EASTMED INC.
  SUBSTANTIALLY EQUIVALENT 1
EIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
PROCTER & GAMBLE
  SUBSTANTIALLY EQUIVALENT 1
RESILIA INC.
  SUBSTANTIALLY EQUIVALENT 1
RINOVUM SUBSIDIARY 2, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 1 1
2016 6 6
2017 5 5
2018 3 3
2019 15 15
2020 401 401
2021 24 24
2022 14 14
2023 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 177 177
Break 100 100
Component Missing 67 67
Difficult to Remove 48 48
Material Too Rigid or Stiff 43 43
Product Quality Problem 23 23
Difficult to Insert 16 16
Sharp Edges 9 9
Insufficient Information 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Use of Device Problem 7 7
Patient-Device Incompatibility 6 6
Material Integrity Problem 4 4
Output Problem 3 3
Material Discolored 3 3
Material Erosion 3 3
Inadequacy of Device Shape and/or Size 2 2
Device Operates Differently Than Expected 2 2
Structural Problem 2 2
Defective Device 2 2
Physical Resistance/Sticking 2 2
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Scratched Material 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Material Puncture/Hole 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 216 216
No Known Impact Or Consequence To Patient 116 116
Pain 52 52
No Clinical Signs, Symptoms or Conditions 40 40
Discomfort 23 23
Hemorrhage/Bleeding 10 10
Unspecified Infection 9 9
Insufficient Information 9 9
Abnormal Vaginal Discharge 7 7
Urinary Tract Infection 6 6
Laceration(s) 6 6
Blood Loss 6 6
Genital Bleeding 6 6
Intermenstrual Bleeding 5 5
Abdominal Pain 5 5
Abrasion 4 4
Irritation 4 4
Fever 3 3
Fistula 3 3
Rash 3 3
Burning Sensation 3 3
Injury 3 3
No Code Available 3 3
Foreign Body In Patient 3 3
Cramp(s) /Muscle Spasm(s) 2 2
Ulcer 2 2
Incontinence 2 2
Adhesion(s) 2 2
Bacterial Infection 2 2
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 1 1
Itching Sensation 1 1
Nausea 1 1
Perforation 1 1
Hair Loss 1 1
Headache 1 1
Hematoma 1 1
Vaginal Mucosa Damage 1 1
Renal Failure 1 1
Sepsis 1 1
Swelling 1 1
Thyroid Problems 1 1
Tissue Damage 1 1
Urinary Frequency 1 1
Urticaria 1 1
Anxiety 1 1
Cramp(s) 1 1
Anaphylactoid 1 1
Discharge 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Dyspareunia 1 1
Weight Changes 1 1
Reaction 1 1
Fungal Infection 1 1
Irritability 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Heavier Menses 1 1
Dysuria 1 1
Fluid Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cooper Surgical, Inc. III Mar-27-2013
2 CooperSurgical, Inc. II Feb-26-2021
3 CooperSurgical, Inc. II May-09-2017
4 CooperSurgical, Inc. III Nov-10-2015
5 CooperSurgical, Inc. II Mar-03-2015
6 CooperSurgical, Inc. III Nov-13-2014
7 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
8 Rinovum Women's Health II Jul-09-2019
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