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 device, impotence, mechanical/hydraulic
Definition PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Product CodeFHW
Regulation Number 876.3350
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
3 4 2 3 3 1

MDR Year MDR Reports MDR Events
2019 4010 4010
2020 3562 3562
2021 3720 3720
2022 3203 3203
2023 3675 3675
2024 1024 1024

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 4228 4228
Fluid/Blood Leak 3899 3899
Inflation Problem 3592 3592
Adverse Event Without Identified Device or Use Problem 3241 3241
Material Puncture/Hole 2567 2567
Insufficient Information 2014 2014
Migration 1164 1164
Fracture 1021 1021
Inadequacy of Device Shape and/or Size 809 809
Collapse 719 719
Defective Device 690 690
Break 680 680
Deflation Problem 669 669
Malposition of Device 470 470
Pumping Problem 444 444
Degraded 385 385
Leak/Splash 360 360
Appropriate Term/Code Not Available 214 214
Material Deformation 198 198
Failure to Cycle 191 191
Material Split, Cut or Torn 102 102
Positioning Problem 97 97
Use of Device Problem 89 89
Air/Gas in Device 77 77
Migration or Expulsion of Device 69 69
Physical Resistance/Sticking 66 66
Device Appears to Trigger Rejection 60 60
Crack 58 58
Free or Unrestricted Flow 56 56
Material Protrusion/Extrusion 55 55
Material Erosion 54 54
Connection Problem 53 53
Material Twisted/Bent 53 53
Failure to Pump 52 52
Infusion or Flow Problem 50 50
Missing Information 48 48
Unintended Deflation 44 44
No Apparent Adverse Event 41 41
Difficult or Delayed Activation 38 38
Failure to Deflate 35 35
Mechanical Jam 34 34
Material Frayed 34 34
Patient Device Interaction Problem 22 22
Noise, Audible 21 21
Material Discolored 20 20
Device Dislodged or Dislocated 18 18
Device Contamination with Chemical or Other Material 17 17
Device Contaminated During Manufacture or Shipping 17 17
Material Rupture 13 13
Detachment of Device or Device Component 12 12
Disconnection 12 12
Filling Problem 12 12
Separation Problem 12 12
Loose or Intermittent Connection 11 11
Patient-Device Incompatibility 11 11
Self-Activation or Keying 11 11
Material Perforation 11 11
Defective Component 8 8
Deformation Due to Compressive Stress 8 8
Device Markings/Labelling Problem 8 8
Gas/Air Leak 8 8
Obstruction of Flow 7 7
Tear, Rip or Hole in Device Packaging 7 7
Premature Activation 7 7
Difficult to Insert 6 6
Contamination 6 6
Complete Blockage 5 5
Naturally Worn 5 5
Labelling, Instructions for Use or Training Problem 4 4
Material Separation 4 4
Material Too Rigid or Stiff 4 4
Short Fill 3 3
Device Damaged by Another Device 3 3
No Flow 3 3
Improper Flow or Infusion 3 3
Inadequate User Interface 2 2
Material Integrity Problem 2 2
Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Wrong Label 2 2
Device-Device Incompatibility 2 2
Contamination /Decontamination Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Unexpected Therapeutic Results 2 2
Pumping Stopped 2 2
Inability to Auto-Fill 2 2
Calcified 2 2
Corroded 1 1
Flaked 1 1
Difficult or Delayed Positioning 1 1
Device Difficult to Setup or Prepare 1 1
Decrease in Pressure 1 1
Off-Label Use 1 1
Material Invagination 1 1
Excess Flow or Over-Infusion 1 1
Misassembled 1 1
Unintended System Motion 1 1
Fitting Problem 1 1
Overfill 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8437 8437
No Known Impact Or Consequence To Patient 3666 3666
No Consequences Or Impact To Patient 1667 1667
Unspecified Infection 1642 1642
Pain 888 888
No Information 824 824
Erosion 787 787
Insufficient Information 483 483
Discomfort 434 434
Perforation 276 276
Bacterial Infection 204 204
Failure of Implant 196 196
Swelling/ Edema 123 123
Scar Tissue 106 106
Capsular Contracture 105 105
Wound Dehiscence 94 94
Complaint, Ill-Defined 88 88
Inflammation 85 85
Hematoma 80 80
Adhesion(s) 70 70
Skin Erosion 62 62
Purulent Discharge 59 59
Hernia 49 49
Fluid Discharge 47 47
Swelling 47 47
Tissue Damage 44 44
Unspecified Tissue Injury 35 35
Deformity/ Disfigurement 33 33
Hemorrhage/Bleeding 29 29
Scarring 25 25
No Code Available 24 24
Urinary Retention 23 23
Dysuria 21 21
Fever 20 20
Fistula 19 19
Abscess 19 19
Fibrosis 19 19
Depression 19 19
Impaired Healing 19 19
Injury 18 18
Abdominal Pain 17 17
Hypersensitivity/Allergic reaction 17 17
Urinary Tract Infection 16 16
Anxiety 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Impotence 15 15
Aneurysm 15 15
Numbness 14 14
Post Operative Wound Infection 12 12
Edema 12 12
Bruise/Contusion 11 11
Burning Sensation 11 11
Unspecified Mental, Emotional or Behavioural Problem 11 11
Pocket Erosion 10 10
Therapeutic Effects, Unexpected 10 10
Itching Sensation 9 9
Urinary Incontinence 9 9
Skin Inflammation/ Irritation 9 9
Incontinence 8 8
Necrosis 8 8
Sepsis 8 8
Perforation of Vessels 7 7
Seroma 7 7
Dyspareunia 7 7
Hematuria 7 7
Obstruction/Occlusion 6 6
Internal Organ Perforation 6 6
Cellulitis 6 6
Micturition Urgency 6 6
Irritation 5 5
Emotional Changes 5 5
Nerve Damage 5 5
Urinary Frequency 5 5
Discharge 5 5
Blood Loss 5 5
Foreign Body In Patient 5 5
Urethral Stenosis/Stricture 5 5
No Patient Involvement 4 4
Bowel Perforation 4 4
Diaphoresis 4 4
Rash 4 4
Cardiac Arrest 4 4
Ischemia 4 4
Arrhythmia 3 3
Muscle Weakness 3 3
Neuropathy 3 3
Tachycardia 3 3
Thrombosis 3 3
Fungal Infection 3 3
Unspecified Kidney or Urinary Problem 3 3
Implant Pain 3 3
Genital Bleeding 3 3
Constipation 3 3
Sexual Dysfunction 2 2
Erectile Dysfunction 2 2
Localized Skin Lesion 2 2
Patient Problem/Medical Problem 2 2
Cognitive Changes 2 2
Abdominal Distention 2 2
Ulcer 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Manufacturing US, LLC II Apr-12-2023
2 Coloplast Manufacturing US, LLC II Dec-22-2021
3 Coloplast Manufacturing US, LLC II Nov-25-2020
-
-