Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, penile
Product CodeFAE
Regulation Number 876.3630
Device Class 2


Premarket Reviews
ManufacturerDecision
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 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 573 573
Adverse Event Without Identified Device or Use Problem 380 380
Inadequacy of Device Shape and/or Size 106 106
Mechanical Problem 100 100
Defective Device 59 59
Migration 53 53
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 Information 251 251
No Clinical Signs, Symptoms or Conditions 243 243
No Known Impact Or Consequence To Patient 237 237
Unspecified Infection 225 225
Erosion 161 161
Pain 138 138
Perforation 75 75
Discomfort 49 49
Insufficient Information 33 33
No Consequences Or Impact To Patient 32 32
Failure of Implant 28 28
Bacterial Infection 20 20
No Code Available 18 18
Therapeutic Response, Decreased 14 14
Inflammation 12 12
Wound Dehiscence 11 11
Skin Erosion 10 10
Necrosis 9 9
Hematoma 9 9
Purulent Discharge 8 8
Injury 8 8
Swelling/ Edema 7 7
Deformity/ Disfigurement 6 6
Complaint, Ill-Defined 6 6
Tissue Damage 6 6
Edema 6 6
Fistula 5 5
Scarring 5 5
Unspecified Tissue Injury 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
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
Hemorrhage/Bleeding 2 2
Ecchymosis 2 2
Cardiac Arrest 2 2
Cellulitis 2 2
Abscess 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
Bruise/Contusion 1 1
Stroke/CVA 1 1
Emotional Changes 1 1
Erythema 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
-
-