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TPLC
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show TPLC since
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Device
pessary, vaginal
Product Code
HHW
Regulation Number
884.3575
Device Class
2
Premarket Reviews
Manufacturer
Decision
CONTIPI LTD.
SUBSTANTIALLY EQUIVALENT
1
CONTIPI MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
COSM MEDICAL
SUBSTANTIALLY EQUIVALENT
1
EASTMED INC.
SUBSTANTIALLY EQUIVALENT
1
EIS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
PANPAC MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
4
PROCTER & GAMBLE
SUBSTANTIALLY EQUIVALENT
1
REIA, LLC
SUBSTANTIALLY EQUIVALENT
1
RESILIA INC.
SUBSTANTIALLY EQUIVALENT
1
RINOVUM SUBSIDIARY 2, LLC
SUBSTANTIALLY EQUIVALENT
1
WATKINS-CONTI PRODUCTS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
1
1
2016
6
6
2017
5
5
2018
3
3
2019
15
15
2020
401
401
2021
24
24
2022
14
14
2023
12
12
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
179
179
Break
100
100
Component Missing
67
67
Difficult to Remove
48
48
Material Too Rigid or Stiff
43
43
Product Quality Problem
23
23
Difficult to Insert
16
16
Sharp Edges
9
9
Use of Device Problem
8
8
Insufficient Information
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Patient-Device Incompatibility
6
6
Material Integrity Problem
4
4
Output Problem
3
3
Material Erosion
3
3
Material Discolored
3
3
Physical Resistance/Sticking
2
2
Structural Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Defective Device
2
2
Device Operates Differently Than Expected
2
2
Material Split, Cut or Torn
1
1
Device Damaged Prior to Use
1
1
Crack
1
1
Material Puncture/Hole
1
1
Scratched Material
1
1
Microbial Contamination of Device
1
1
Patient Device Interaction Problem
1
1
Material Fragmentation
1
1
Fluid/Blood Leak
1
1
Defective Component
1
1
Positioning Problem
1
1
Manufacturing, Packaging or Shipping Problem
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
216
216
No Known Impact Or Consequence To Patient
116
116
Pain
52
52
No Clinical Signs, Symptoms or Conditions
42
42
Discomfort
23
23
Hemorrhage/Bleeding
10
10
Unspecified Infection
9
9
Insufficient Information
9
9
Abnormal Vaginal Discharge
7
7
Urinary Tract Infection
6
6
Laceration(s)
6
6
Genital Bleeding
6
6
Blood Loss
6
6
Abdominal Pain
5
5
Intermenstrual Bleeding
5
5
Irritation
4
4
Abrasion
4
4
Fistula
3
3
Foreign Body In Patient
3
3
Injury
3
3
Fever
3
3
Rash
3
3
Burning Sensation
3
3
No Code Available
3
3
Cramp(s) /Muscle Spasm(s)
2
2
Adhesion(s)
2
2
Incontinence
2
2
Ulcer
2
2
Hypersensitivity/Allergic reaction
2
2
Bacterial Infection
2
2
Itching Sensation
1
1
Anaphylactoid
1
1
Vaginal Mucosa Damage
1
1
Perforation
1
1
Hematoma
1
1
Heavier Menses
1
1
Skin Inflammation/ Irritation
1
1
Dysuria
1
1
Fungal Infection
1
1
Failure of Implant
1
1
Cramp(s)
1
1
Swelling
1
1
Dyspareunia
1
1
Sepsis
1
1
Hair Loss
1
1
Nausea
1
1
Reaction
1
1
Fluid Discharge
1
1
Rectovaginal Fistula
1
1
Renal Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cooper Surgical, Inc.
III
Mar-27-2013
2
CooperSurgical, Inc.
II
Feb-26-2021
3
CooperSurgical, Inc.
II
May-09-2017
4
CooperSurgical, Inc.
III
Nov-10-2015
5
CooperSurgical, Inc.
II
Mar-03-2015
6
CooperSurgical, Inc.
III
Nov-13-2014
7
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
8
Rinovum Women's Health
II
Jul-09-2019
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