Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 27 27
Product Quality Problem 26 26
Difficult to Remove 12 12
Break 6 6
Use of Device Problem 4 4
Output Problem 3 3
Insufficient Information 2 2
Patient Device Interaction Problem 2 2
Material Too Rigid or Stiff 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Dislodged or Dislocated 2 2
Crack 1 1
Material Puncture/Hole 1 1
Patient-Device Incompatibility 1 1
Defective Component 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Scratched Material 1 1
Component Missing 1 1
Material Protrusion/Extrusion 1 1
Appropriate Term/Code Not Available 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
Pain 12 12
Foreign Body In Patient 7 7
Genital Bleeding 7 7
Insufficient Information 6 6
Discomfort 5 5
Abrasion 5 5
Hemorrhage/Bleeding 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Unspecified Tissue Injury 2 2
Rectovaginal Fistula 2 2
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 2 2
Adhesion(s) 2 2
Abnormal Vaginal Discharge 2 2
No Consequences Or Impact To Patient 2 2
Rupture 1 1
Ulcer 1 1
Urticaria 1 1
Vaginal Mucosa Damage 1 1
Burning Sensation 1 1
Rash 1 1
Urinary Retention 1 1
Fever 1 1
Hematoma 1 1
Unspecified Infection 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Device Embedded In Tissue or Plaque 1 1
Malaise 1 1
Irritability 1 1
Ambulation Difficulties 1 1
Intermenstrual Bleeding 1 1
Abdominal Pain 1 1
Skin Inflammation/ Irritation 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
-
-