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TPLC
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Device
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
Definition
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Product Code
PAH
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
CALDERA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
COLOPLAST A/S
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
297
297
2020
171
171
2021
318
318
2022
159
159
2023
154
154
2024
75
75
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
587
587
Migration
149
149
Insufficient Information
86
86
Appropriate Term/Code Not Available
82
82
Break
81
81
Detachment of Device or Device Component
44
44
Material Protrusion/Extrusion
28
28
Material Twisted/Bent
23
23
Device Appears to Trigger Rejection
23
23
No Apparent Adverse Event
19
19
Positioning Problem
17
17
Positioning Failure
15
15
Material Erosion
15
15
Material Deformation
15
15
Difficult to Advance
11
11
Migration or Expulsion of Device
11
11
Defective Device
10
10
Material Split, Cut or Torn
9
9
Fracture
8
8
Patient-Device Incompatibility
7
7
Premature Activation
7
7
Patient Device Interaction Problem
7
7
Missing Information
6
6
Device Dislodged or Dislocated
5
5
Material Fragmentation
4
4
Loose or Intermittent Connection
3
3
Material Separation
3
3
Difficult or Delayed Separation
3
3
Separation Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Improper or Incorrect Procedure or Method
2
2
Defective Component
1
1
Malposition of Device
1
1
Deformation Due to Compressive Stress
1
1
Activation, Positioning or Separation Problem
1
1
Device-Device Incompatibility
1
1
Human-Device Interface Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Unstable
1
1
Difficult to Remove
1
1
Material Too Rigid or Stiff
1
1
Mechanical Problem
1
1
Unsealed Device Packaging
1
1
Material Frayed
1
1
Leak/Splash
1
1
Disconnection
1
1
Degraded
1
1
Difficult or Delayed Positioning
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Therapeutic or Diagnostic Output Failure
1
1
Activation Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
479
479
Erosion
343
343
Incontinence
190
190
Injury
168
168
Dyspareunia
150
150
Urinary Tract Infection
136
136
Urinary Incontinence
135
135
No Clinical Signs, Symptoms or Conditions
131
131
Urinary Retention
107
107
Micturition Urgency
102
102
Insufficient Information
100
100
Dysuria
76
76
Unspecified Infection
71
71
No Code Available
69
69
Urinary Frequency
68
68
Prolapse
62
62
Scar Tissue
62
62
Abnormal Vaginal Discharge
61
61
Inflammation
57
57
Not Applicable
57
57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
53
53
Constipation
49
49
Discomfort
48
48
Hematuria
45
45
Abdominal Pain
37
37
No Consequences Or Impact To Patient
36
36
Foreign Body Reaction
34
34
Intermenstrual Bleeding
32
32
Bacterial Infection
29
29
Cramp(s) /Muscle Spasm(s)
29
29
Hemorrhage/Bleeding
27
27
Burning Sensation
27
27
Genital Bleeding
26
26
No Information
24
24
Depression
21
21
Obstruction/Occlusion
21
21
Unspecified Kidney or Urinary Problem
20
20
Perforation
18
18
Nerve Damage
18
18
Muscle Weakness
17
17
Foreign Body In Patient
16
16
Anxiety
16
16
Skin Erosion
16
16
Unspecified Mental, Emotional or Behavioural Problem
16
16
Nausea
15
15
Adhesion(s)
15
15
Fistula
14
14
Emotional Changes
13
13
Blood Loss
13
13
Deformity/ Disfigurement
13
13
Kidney Infection
13
13
Sexual Dysfunction
13
13
Device Embedded In Tissue or Plaque
12
12
Fatigue
12
12
Fever
12
12
Abscess
12
12
Failure of Implant
12
12
Pocket Erosion
12
12
Internal Organ Perforation
11
11
Hypersensitivity/Allergic reaction
10
10
Itching Sensation
10
10
Numbness
10
10
Tissue Damage
10
10
Vomiting
10
10
Swelling/ Edema
10
10
Fecal Incontinence
9
9
Distress
9
9
Fibrosis
9
9
Disability
8
8
Sepsis
8
8
Wound Dehiscence
8
8
Skin Inflammation/ Irritation
8
8
Unspecified Tissue Injury
7
7
Cyst(s)
7
7
Hematoma
7
7
No Known Impact Or Consequence To Patient
7
7
Sleep Dysfunction
7
7
Abdominal Cramps
7
7
Fungal Infection
6
6
Diarrhea
6
6
Anemia
6
6
Neuralgia
6
6
Calcium Deposits/Calcification
5
5
Chest Pain
5
5
Scarring
5
5
Swelling
5
5
Rash
5
5
Myalgia
4
4
Stenosis
4
4
Weight Changes
4
4
Headache
4
4
High Blood Pressure/ Hypertension
4
4
Erythema
4
4
Edema
3
3
Muscle Spasm(s)
3
3
Low Blood Pressure/ Hypotension
3
3
Nervous System Injury
3
3
Lethargy
3
3
Fluid Discharge
3
3
Skin Tears
3
3
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