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TPLC
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Device
pessary, vaginal
Regulation Description
Vaginal pessary.
Product Code
HHW
Regulation Number
884.3575
Device Class
2
Premarket Reviews
Manufacturer
Decision
CNTRL+ 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
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
181
181
Break
93
93
Component Missing
66
66
Difficult to Remove
46
46
Material Too Rigid or Stiff
43
43
Product Quality Problem
26
26
Difficult to Insert
15
15
Sharp Edges
9
9
Use of Device Problem
7
7
Material Integrity Problem
3
3
Output Problem
3
3
Material Discolored
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Patient-Device Incompatibility
2
2
Defective Device
2
2
Physical Resistance/Sticking
2
2
Insufficient Information
2
2
Structural Problem
2
2
Material Fragmentation
1
1
Material Erosion
1
1
Defective Component
1
1
Material Puncture/Hole
1
1
Patient Device Interaction Problem
1
1
Scratched Material
1
1
Inadequacy of Device Shape and/or Size
1
1
Microbial Contamination of Device
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Crack
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
Pain
45
45
No Clinical Signs, Symptoms or Conditions
45
45
Discomfort
17
17
Insufficient Information
9
9
Abnormal Vaginal Discharge
7
7
Unspecified Infection
7
7
Laceration(s)
6
6
Genital Bleeding
5
5
Intermenstrual Bleeding
5
5
Foreign Body In Patient
4
4
Abrasion
4
4
Irritation
4
4
Hemorrhage/Bleeding
3
3
Cramp(s) /Muscle Spasm(s)
2
2
Hypersensitivity/Allergic reaction
2
2
Injury
2
2
Abdominal Pain
2
2
Ulcer
2
2
Urinary Tract Infection
2
2
Adhesion(s)
2
2
Bacterial Infection
2
2
Burning Sensation
2
2
Swelling
1
1
Dyspareunia
1
1
Tissue Damage
1
1
Incontinence
1
1
Dysuria
1
1
Fungal Infection
1
1
Rectovaginal Fistula
1
1
Blood Loss
1
1
Cramp(s)
1
1
Rash
1
1
Unspecified Tissue Injury
1
1
Anxiety
1
1
Hematoma
1
1
Fever
1
1
Irritability
1
1
Urticaria
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
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