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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
RESILIA INC.
  SUBSTANTIALLY EQUIVALENT 1
RINOVUM SUBSIDIARY 2, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 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 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Output Problem 3 3
Material Integrity Problem 3 3
Patient-Device Incompatibility 3 3
Material Discolored 3 3
Material Erosion 3 3
Structural Problem 2 2
Defective Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Insufficient Information 2 2
Physical Resistance/Sticking 2 2
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Scratched Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Material Fragmentation 1 1
Crack 1 1
Material Puncture/Hole 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 40 40
Discomfort 19 19
Insufficient Information 9 9
Abnormal Vaginal Discharge 7 7
Unspecified Infection 6 6
Hemorrhage/Bleeding 6 6
Laceration(s) 5 5
Intermenstrual Bleeding 5 5
Urinary Tract Infection 4 4
Irritation 4 4
Abrasion 4 4
Genital Bleeding 4 4
Foreign Body In Patient 3 3
Blood Loss 3 3
Injury 3 3
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
Cramp(s) /Muscle Spasm(s) 2 2
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Dyspareunia 1 1
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

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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