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TPLC
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Device
pessary, vaginal
Product Code
HHW
Regulation Number
884.3575
Device Class
2
Premarket Reviews
Manufacturer
Decision
CONTIPI MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
COSM MEDICAL
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
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
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
7
7
Adverse Event Without Identified Device or Use Problem
5
5
Material Discolored
3
3
Output Problem
3
3
Material Erosion
3
3
Patient-Device Incompatibility
3
3
Material Integrity Problem
3
3
Physical Resistance/Sticking
2
2
Insufficient Information
2
2
Defective Device
2
2
Structural Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Damaged Prior to Use
1
1
Crack
1
1
Material Puncture/Hole
1
1
Defective Component
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Device Interaction Problem
1
1
Microbial Contamination of Device
1
1
Scratched Material
1
1
Material Fragmentation
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
114
114
Pain
47
47
No Clinical Signs, Symptoms or Conditions
42
42
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
Genital Bleeding
4
4
Abrasion
4
4
Irritation
4
4
Blood Loss
3
3
Foreign Body In Patient
3
3
Injury
3
3
Fistula
2
2
Bacterial Infection
2
2
Ulcer
2
2
Burning Sensation
2
2
Rash
2
2
Incontinence
2
2
Cramp(s) /Muscle Spasm(s)
2
2
Adhesion(s)
2
2
Hypersensitivity/Allergic reaction
2
2
Abdominal Pain
2
2
Vaginal Mucosa Damage
1
1
Fever
1
1
Itching Sensation
1
1
Cramp(s)
1
1
Swelling
1
1
Dyspareunia
1
1
Perforation
1
1
Skin Inflammation/ Irritation
1
1
Fluid Discharge
1
1
Rectovaginal Fistula
1
1
Anxiety
1
1
Unspecified Tissue Injury
1
1
Discharge
1
1
Tissue Damage
1
1
Dysuria
1
1
Fungal Infection
1
1
Failure of Implant
1
1
Irritability
1
1
Urticaria
1
1
Ambulation Difficulties
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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