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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
COOPERSURGICAL 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 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 190 190
Break 93 93
Component Missing 66 66
Difficult to Remove 46 46
Product Quality Problem 44 44
Material Too Rigid or Stiff 43 43
Difficult to Insert 15 15
Use of Device Problem 10 10
Sharp Edges 9 9
Output Problem 3 3
Material Integrity Problem 3 3
Material Discolored 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Physical Resistance/Sticking 2 2
Patient-Device Incompatibility 2 2
Insufficient Information 2 2
Defective Device 2 2
Patient Device Interaction Problem 2 2
Structural Problem 2 2
Crack 1 1
Material Erosion 1 1
Material Puncture/Hole 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Microbial Contamination of Device 1 1
Scratched Material 1 1
Material Fragmentation 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Protrusion/Extrusion 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
No Clinical Signs, Symptoms or Conditions 63 63
Pain 52 52
Discomfort 18 18
Insufficient Information 9 9
Unspecified Infection 7 7
Genital Bleeding 7 7
Abnormal Vaginal Discharge 7 7
Abrasion 7 7
Foreign Body In Patient 7 7
Laceration(s) 6 6
Hemorrhage/Bleeding 5 5
Intermenstrual Bleeding 5 5
Irritation 4 4
Cramp(s) /Muscle Spasm(s) 3 3
Abdominal Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Urinary Tract Infection 2 2
Adhesion(s) 2 2
Bacterial Infection 2 2
Ulcer 2 2
Unspecified Tissue Injury 2 2
Rectovaginal Fistula 2 2
Burning Sensation 2 2
Injury 2 2
Device Embedded In Tissue or Plaque 1 1
Ambulation Difficulties 1 1
Irritability 1 1
Tissue Damage 1 1
Anxiety 1 1
Dyspareunia 1 1
Cramp(s) 1 1
Urinary Retention 1 1
Swelling 1 1
Rash 1 1
Fever 1 1
Vaginal Mucosa Damage 1 1
Incontinence 1 1
Blood Loss 1 1
Rupture 1 1
Malaise 1 1
Hematoma 1 1
Skin Inflammation/ Irritation 1 1
Dysuria 1 1
Fungal Infection 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
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