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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
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RINOVUM SUBSIDIARY 2, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3 3
2019 15 15
2020 401 401
2021 24 24
2022 14 14
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 177 177
Break 98 98
Component Missing 66 66
Material Too Rigid or Stiff 43 43
Difficult to Remove 42 42
Product Quality Problem 23 23
Difficult to Insert 16 16
Sharp Edges 9 9
Use of Device Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Output Problem 3 3
Patient-Device Incompatibility 3 3
Material Integrity Problem 3 3
Material Discolored 3 3
Material Erosion 3 3
Inadequacy of Device Shape and/or Size 2 2
Physical Resistance/Sticking 2 2
Insufficient Information 2 2
Structural Problem 2 2
Defective Device 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Scratched Material 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Material Split, Cut or Torn 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 114 114
Pain 48 48
No Clinical Signs, Symptoms or Conditions 35 35
Discomfort 20 20
Hemorrhage/Bleeding 9 9
Insufficient Information 9 9
Unspecified Infection 7 7
Abnormal Vaginal Discharge 7 7
Genital Bleeding 6 6
Intermenstrual Bleeding 5 5
Laceration(s) 5 5
Irritation 4 4
Abrasion 4 4
Urinary Tract Infection 4 4
Blood Loss 3 3
Injury 3 3
Foreign Body In Patient 3 3
Cramp(s) /Muscle Spasm(s) 2 2
Burning Sensation 2 2
Ulcer 2 2
Adhesion(s) 2 2
Bacterial Infection 2 2
Hypersensitivity/Allergic reaction 2 2
Abdominal Pain 2 2
Fistula 2 2
Incontinence 2 2
Rash 2 2
Swelling 1 1
Tissue Damage 1 1
Perforation 1 1
Itching Sensation 1 1
Failure of Implant 1 1
Fever 1 1
Urticaria 1 1
Anxiety 1 1
Discharge 1 1
Cramp(s) 1 1
Vaginal Mucosa Damage 1 1
Fungal Infection 1 1
Irritability 1 1
Ambulation Difficulties 1 1
Dysuria 1 1
Fluid Discharge 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Dyspareunia 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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