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TPLC
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show TPLC since
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Device
prosthesis, penile
Product Code
FAE
Regulation Number
876.3630
Device Class
2
Premarket Reviews
Manufacturer
Decision
AMERICAN MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
RIGICON INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
75
75
2015
98
98
2016
104
104
2017
123
123
2018
127
127
2019
221
221
2020
163
163
2021
167
167
2022
168
168
2023
160
160
2024
63
63
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
576
576
Adverse Event Without Identified Device or Use Problem
393
393
Inadequacy of Device Shape and/or Size
109
109
Mechanical Problem
102
102
Defective Device
61
61
Migration
57
57
Device Operates Differently Than Expected
37
37
Fracture
35
35
Malposition of Device
31
31
Break
25
25
Migration or Expulsion of Device
20
20
Appropriate Term/Code Not Available
14
14
Material Puncture/Hole
13
13
Extrusion
12
12
Use of Device Problem
11
11
Fluid/Blood Leak
9
9
Material Erosion
8
8
Device Inoperable
6
6
Positioning Problem
6
6
Noise, Audible
5
5
Material Too Soft/Flexible
5
5
Device Appears to Trigger Rejection
5
5
Inflation Problem
4
4
Material Protrusion/Extrusion
4
4
No Apparent Adverse Event
3
3
Difficult to Insert
3
3
Contamination
3
3
Device Dislodged or Dislocated
3
3
Detachment of Device or Device Component
2
2
Crack
2
2
Degraded
2
2
Material Discolored
2
2
Leak/Splash
2
2
Material Deformation
2
2
Patient Device Interaction Problem
2
2
Material Twisted/Bent
2
2
Naturally Worn
1
1
Device Contamination with Chemical or Other Material
1
1
Pumping Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Missing Information
1
1
Incorrect Measurement
1
1
Material Too Rigid or Stiff
1
1
Peeled/Delaminated
1
1
Air Leak
1
1
Deflation Problem
1
1
Burst Container or Vessel
1
1
Device Markings/Labelling Problem
1
1
Device Operational Issue
1
1
Defective Component
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Tear, Rip or Hole in Device Packaging
1
1
Patient-Device Incompatibility
1
1
Deformation Due to Compressive Stress
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
252
252
No Information
251
251
No Known Impact Or Consequence To Patient
237
237
Unspecified Infection
230
230
Erosion
167
167
Pain
143
143
Perforation
77
77
Discomfort
51
51
Insufficient Information
34
34
No Consequences Or Impact To Patient
32
32
Failure of Implant
32
32
Bacterial Infection
20
20
No Code Available
18
18
Therapeutic Response, Decreased
14
14
Inflammation
12
12
Necrosis
11
11
Wound Dehiscence
11
11
Purulent Discharge
10
10
Skin Erosion
10
10
Hematoma
9
9
Injury
8
8
Swelling/ Edema
7
7
Unspecified Tissue Injury
6
6
Deformity/ Disfigurement
6
6
Complaint, Ill-Defined
6
6
Tissue Damage
6
6
Edema
6
6
Fistula
5
5
Scarring
5
5
Fluid Discharge
4
4
Urinary Retention
4
4
Irritation
4
4
Swelling
3
3
Therapeutic Effects, Unexpected
3
3
Hypersensitivity/Allergic reaction
3
3
Fever
3
3
Cardiac Arrest
3
3
Urinary Tract Infection
3
3
Depression
3
3
Fibrosis
3
3
Post Operative Wound Infection
3
3
Numbness
3
3
Fungal Infection
2
2
Obstruction/Occlusion
2
2
No Patient Involvement
2
2
Urinary Frequency
2
2
Burning Sensation
2
2
Cellulitis
2
2
Ecchymosis
2
2
Abscess
2
2
Hemorrhage/Bleeding
2
2
Scar Tissue
2
2
Rash
2
2
Sexual Dysfunction
2
2
Patient Problem/Medical Problem
2
2
Skin Inflammation/ Irritation
2
2
Localized Skin Lesion
1
1
Renal Failure
1
1
Pocket Erosion
1
1
Myocardial Infarction
1
1
Nausea
1
1
Nerve Damage
1
1
Neurological Deficit/Dysfunction
1
1
Occlusion
1
1
Emotional Changes
1
1
Erythema
1
1
Bruise/Contusion
1
1
Stroke/CVA
1
1
Chills
1
1
Ulcer
1
1
Ventricular Tachycardia
1
1
Vomiting
1
1
Weakness
1
1
Anxiety
1
1
Dyskinesia
1
1
Impaired Healing
1
1
Inadequate Pain Relief
1
1
Blood Loss
1
1
Weight Changes
1
1
Sensitivity of Teeth
1
1
Sweating
1
1
Foreign Body In Patient
1
1
Urethral Stenosis/Stricture
1
1
Unspecified Kidney or Urinary Problem
1
1
Dyspareunia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Coloplast Manufacturing US, LLC
II
Apr-27-2015
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