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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 MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
COSM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
REIA, LLC
  SUBSTANTIALLY EQUIVALENT 1
RESILIA INC.
  SUBSTANTIALLY EQUIVALENT 1
RINOVUM SUBSIDIARY 2, LLC
  SUBSTANTIALLY EQUIVALENT 1
WATKINS-CONTI PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 401 401
2021 24 24
2022 14 14
2023 12 12
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 179 179
Break 98 98
Component Missing 67 67
Difficult to Remove 46 46
Material Too Rigid or Stiff 43 43
Product Quality Problem 23 23
Difficult to Insert 15 15
Sharp Edges 9 9
Use of Device Problem 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Output Problem 3 3
Patient-Device Incompatibility 3 3
Material Erosion 3 3
Material Integrity Problem 3 3
Material Discolored 3 3
Physical Resistance/Sticking 2 2
Structural Problem 2 2
Insufficient Information 2 2
Defective Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Patient Device Interaction Problem 1 1
Microbial Contamination of Device 1 1
Scratched Material 1 1
Material Fragmentation 1 1
Crack 1 1
Device Damaged Prior to Use 1 1
Material Puncture/Hole 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 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 216 216
No Known Impact Or Consequence To Patient 114 114
Pain 47 47
No Clinical Signs, Symptoms or Conditions 42 42
Discomfort 19 19
Insufficient Information 9 9
Abnormal Vaginal Discharge 7 7
Unspecified Infection 6 6
Hemorrhage/Bleeding 6 6
Intermenstrual Bleeding 5 5
Laceration(s) 5 5
Urinary Tract Infection 4 4
Genital Bleeding 4 4
Abrasion 4 4
Irritation 4 4
Blood Loss 3 3
Injury 3 3
Foreign Body In Patient 3 3
Abdominal Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Fistula 2 2
Adhesion(s) 2 2
Bacterial Infection 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Incontinence 2 2
Ulcer 2 2
Rash 2 2
Burning Sensation 2 2
Ambulation Difficulties 1 1
Irritability 1 1
Discharge 1 1
Tissue Damage 1 1
Unspecified Tissue Injury 1 1
Anxiety 1 1
Rectovaginal Fistula 1 1
Fluid Discharge 1 1
Dyspareunia 1 1
Cramp(s) 1 1
Swelling 1 1
Fever 1 1
Vaginal Mucosa Damage 1 1
Itching Sensation 1 1
Perforation 1 1
Skin Inflammation/ Irritation 1 1
Dysuria 1 1
Fungal Infection 1 1
Failure of Implant 1 1
Urticaria 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
3 Rinovum Women's Health II Jul-09-2019
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