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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
COOPER SURGICAL
  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
2021 24 24
2022 14 14
2023 12 12
2024 6 6
2025 39 39
2026 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 29 29
Product Quality Problem 25 25
Difficult to Remove 9 9
Break 6 6
Use of Device Problem 4 4
Device Dislodged or Dislocated 2 2
Insufficient Device Problem Information 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Component Missing 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Patient Device Interaction Problem 1 1
Biocompatibility 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Material Too Rigid or Stiff 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
Pain 14 14
Genital Bleeding 8 8
Foreign Body In Patient 7 7
Insufficient Information 6 6
Abrasion 6 6
Discomfort 5 5
Cramp(s) /Muscle Spasm(s) 3 3
Hemorrhage/Blood Loss/Bleeding 3 3
Unspecified Tissue Injury 2 2
Hypersensitivity/Allergic reaction 2 2
Adhesion(s) 2 2
Rectovaginal Fistula 2 2
Abnormal Vaginal Discharge 2 2
Failure of Implant 2 2
Urinary Retention 2 2
No Consequences Or Impact To Patient 2 2
Perineal injury 1 1
Malaise 1 1
Hematoma 1 1
Laceration(s) 1 1
Intermenstrual Bleeding 1 1
Irritability 1 1
Skin Inflammation/ Irritation 1 1
Ulcer 1 1
Fever 1 1
Pelvic Pain 1 1
Urinary Tract Infection 1 1
Burning Sensation 1 1
Device Embedded In Tissue or Plaque 1 1
Abdominal Pain 1 1
Inadequate Pain Relief 1 1
Vaginal Mucosa Damage 1 1
Rash 1 1
Urticaria 1 1
Kidney Infection 1 1
Vaginal Dryness 1 1
Rupture 1 1
Hemodynamic instability 1 1
Unspecified Infection 1 1
Ambulation or Postural Difficulties 1 1
Itching Sensation 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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