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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, penile
Product CodeFAE
Regulation Number 876.3630
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RIGICON INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 123 123
2018 127 127
2019 221 221
2020 163 163
2021 167 167
2022 168 168
2023 160 160
2024 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 459 459
Adverse Event Without Identified Device or Use Problem 294 294
Inadequacy of Device Shape and/or Size 94 94
Mechanical Problem 85 85
Defective Device 59 59
Migration 53 53
Fracture 32 32
Malposition of Device 26 26
Break 23 23
Device Operates Differently Than Expected 15 15
Migration or Expulsion of Device 14 14
Material Puncture/Hole 13 13
Use of Device Problem 11 11
Appropriate Term/Code Not Available 10 10
Fluid/Blood Leak 8 8
Material Erosion 6 6
Device Appears to Trigger Rejection 5 5
Positioning Problem 5 5
Material Too Soft/Flexible 5 5
Noise, Audible 4 4
Inflation Problem 4 4
Extrusion 4 4
Material Protrusion/Extrusion 4 4
Device Inoperable 3 3
Difficult to Insert 3 3
Contamination 3 3
No Apparent Adverse Event 3 3
Material Deformation 2 2
Patient Device Interaction Problem 2 2
Degraded 2 2
Leak/Splash 2 2
Detachment of Device or Device Component 2 2
Material Twisted/Bent 2 2
Device Dislodged or Dislocated 2 2
Device Operational Issue 1 1
Naturally Worn 1 1
Device Contamination with Chemical or Other Material 1 1
Device Markings/Labelling Problem 1 1
Patient-Device Incompatibility 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Material Too Rigid or Stiff 1 1
Peeled/Delaminated 1 1
Material Discolored 1 1
Air Leak 1 1
Crack 1 1
Deflation Problem 1 1
Pumping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 243 243
No Known Impact Or Consequence To Patient 231 231
Unspecified Infection 170 170
No Information 127 127
Erosion 117 117
Pain 109 109
Perforation 62 62
Discomfort 41 41
Insufficient Information 33 33
No Consequences Or Impact To Patient 30 30
Bacterial Infection 19 19
Failure of Implant 16 16
Wound Dehiscence 11 11
Inflammation 10 10
No Code Available 9 9
Skin Erosion 9 9
Necrosis 8 8
Therapeutic Response, Decreased 7 7
Hematoma 7 7
Purulent Discharge 7 7
Swelling/ Edema 7 7
Unspecified Tissue Injury 5 5
Scarring 5 5
Injury 5 5
Deformity/ Disfigurement 4 4
Complaint, Ill-Defined 4 4
Fluid Discharge 4 4
Edema 4 4
Fistula 4 4
Hypersensitivity/Allergic reaction 3 3
Therapeutic Effects, Unexpected 3 3
Tissue Damage 3 3
Irritation 3 3
Post Operative Wound Infection 3 3
No Patient Involvement 2 2
Numbness 2 2
Fungal Infection 2 2
Swelling 2 2
Depression 2 2
Skin Inflammation/ Irritation 2 2
Fibrosis 2 2
Sexual Dysfunction 2 2
Hemorrhage/Bleeding 2 2
Fever 2 2
Abscess 2 2
Urinary Retention 2 2
Urinary Tract Infection 2 2
Burning Sensation 2 2
Ulcer 1 1
Urinary Frequency 1 1
Pocket Erosion 1 1
Rash 1 1
Scar Tissue 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Emotional Changes 1 1
Ecchymosis 1 1
Myocardial Infarction 1 1
Localized Skin Lesion 1 1
Urethral Stenosis/Stricture 1 1
Unspecified Kidney or Urinary Problem 1 1
Dyspareunia 1 1
Impaired Healing 1 1
Obstruction/Occlusion 1 1
Sensitivity of Teeth 1 1
Sweating 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1

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