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TPLC
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2024
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Device
mesh, surgical, for stress urinary incontinence, male
Definition
surgical treatment of male stress urinary incontinence post-prostatectomy
Product Code
OTM
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
COLOPLAST
SUBSTANTIALLY EQUIVALENT - KIT
1
MDR Year
MDR Reports
MDR Events
2019
406
406
2020
261
261
2021
213
213
2022
199
199
2023
28
28
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
898
898
Adverse Event Without Identified Device or Use Problem
116
116
Mechanical Problem
38
38
Defective Device
21
21
Break
13
13
Material Split, Cut or Torn
9
9
Premature Activation
7
7
Malposition of Device
7
7
Device Dislodged or Dislocated
3
3
Use of Device Problem
3
3
Component Missing
3
3
Device Contamination with Chemical or Other Material
2
2
Connection Problem
2
2
Unsealed Device Packaging
2
2
Fluid/Blood Leak
2
2
Material Frayed
2
2
Inflation Problem
1
1
Difficult to Insert
1
1
Device Appears to Trigger Rejection
1
1
Detachment of Device or Device Component
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Twisted/Bent
1
1
Improper or Incorrect Procedure or Method
1
1
Device Damaged Prior to Use
1
1
Packaging Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Missing Information
1
1
Appropriate Term/Code Not Available
1
1
Migration
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
426
426
Incontinence
226
226
No Clinical Signs, Symptoms or Conditions
205
205
Urinary Incontinence
169
169
Insufficient Information
56
56
No Consequences Or Impact To Patient
34
34
Pain
25
25
Urinary Retention
13
13
Unspecified Infection
8
8
Erosion
8
8
Wound Dehiscence
5
5
Hematoma
5
5
No Code Available
5
5
Urinary Tract Infection
4
4
Perforation
4
4
Complaint, Ill-Defined
3
3
Injury
2
2
Device Embedded In Tissue or Plaque
2
2
Impaired Healing
2
2
Hematuria
2
2
Hemorrhage/Bleeding
2
2
Scar Tissue
2
2
Foreign Body Reaction
2
2
Micturition Urgency
2
2
Stroke/CVA
1
1
Emotional Changes
1
1
Pulmonary Embolism
1
1
Abscess
1
1
Bacterial Infection
1
1
Sepsis
1
1
Thrombosis
1
1
Tissue Damage
1
1
Nerve Damage
1
1
Nerve Proximity Nos (Not Otherwise Specified)
1
1
Foreign Body In Patient
1
1
No Information
1
1
Discomfort
1
1
Hypoesthesia
1
1
Disability
1
1
Pneumonia
1
1
Perforation of Vessels
1
1
Skin Inflammation/ Irritation
1
1
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
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