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TPLC
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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
2
COLOPLAST
SUBSTANTIALLY EQUIVALENT - KIT
1
COLOPLAST A/S
SUBSTANTIALLY EQUIVALENT
4
MDR Year
MDR Reports
MDR Events
2014
72
72
2015
42
42
2016
26
26
2017
16
16
2018
111
111
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
1017
1017
Adverse Event Without Identified Device or Use Problem
215
215
Mechanical Problem
39
39
Defective Device
22
22
Malposition of Device
19
19
Break
15
15
Device Operates Differently Than Expected
12
12
Material Split, Cut or Torn
9
9
Migration or Expulsion of Device
7
7
Premature Activation
7
7
Torn Material
4
4
Use of Device Problem
4
4
Device Dislodged or Dislocated
4
4
Component Missing
3
3
Material Frayed
3
3
Connection Problem
2
2
Appropriate Term/Code Not Available
2
2
Migration
2
2
Unexpected Therapeutic Results
2
2
Fluid/Blood Leak
2
2
Detachment of Device or Device Component
2
2
Difficult to Insert
2
2
Device Contamination with Chemical or Other Material
2
2
Unsealed Device Packaging
2
2
Device Contaminated During Manufacture or Shipping
1
1
Device Damaged Prior to Use
1
1
Material Rupture
1
1
Packaging Problem
1
1
Other (for use when an appropriate device code cannot be identified)
1
1
Shelf Life Exceeded
1
1
Device Or Device Fragments Location Unknown
1
1
Material Integrity Problem
1
1
Device Appears to Trigger Rejection
1
1
Improper or Incorrect Procedure or Method
1
1
Missing Information
1
1
Device Inoperable
1
1
Material Twisted/Bent
1
1
Inflation Problem
1
1
Patient-Device Incompatibility
1
1
Therapeutic or Diagnostic Output Failure
1
1
Extrusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
487
487
Incontinence
360
360
No Clinical Signs, Symptoms or Conditions
205
205
Urinary Incontinence
169
169
Insufficient Information
56
56
Pain
52
52
No Consequences Or Impact To Patient
36
36
Urinary Retention
33
33
Erosion
30
30
Unspecified Infection
16
16
Injury
16
16
No Code Available
8
8
Perforation
8
8
Urinary Tract Infection
7
7
No Information
7
7
Death
6
6
Emotional Changes
5
5
Hematoma
5
5
Wound Dehiscence
5
5
Discomfort
5
5
Complaint, Ill-Defined
5
5
Discharge
4
4
Foreign Body In Patient
4
4
Failure of Implant
4
4
Internal Organ Perforation
4
4
Micturition Urgency
3
3
Fistula
3
3
Abscess
3
3
Hematuria
3
3
Blood Loss
2
2
Device Embedded In Tissue or Plaque
2
2
Disability
2
2
Impaired Healing
2
2
Numbness
2
2
Prolapse
2
2
Foreign Body Reaction
2
2
Hemorrhage/Bleeding
2
2
Tissue Damage
2
2
Scar Tissue
2
2
Scarring
2
2
Sepsis
2
2
Thrombosis
1
1
Inflammation
1
1
Muscle Spasm(s)
1
1
Nerve Damage
1
1
Neurological Deficit/Dysfunction
1
1
Pneumonia
1
1
Perforation of Vessels
1
1
Burning Sensation
1
1
Tingling
1
1
Fever
1
1
Atrial Fibrillation
1
1
Bacterial Infection
1
1
Bleeding
1
1
Pulmonary Embolism
1
1
Stroke/CVA
1
1
Shaking/Tremors
1
1
Collapse
1
1
Reaction
1
1
Hypoesthesia
1
1
Surgical procedure
1
1
Therapeutic Response, Decreased
1
1
Urinary Frequency
1
1
Distress
1
1
Other (for use when an appropriate patient code cannot be identified)
1
1
Fibrosis
1
1
Weight Changes
1
1
Nerve Proximity Nos (Not Otherwise Specified)
1
1
Dysuria
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
Recalls
Manufacturer
Recall Class
Date Posted
1
American Medical Systems, Inc.
II
Dec-16-2014
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