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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, urological
Product CodeKOD
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CONVATEC LTD.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLUROMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
ROBLING MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
UROGEN PHARMA LTD
  SUBSTANTIALLY EQUIVALENT 1
UROGEN PHARMA LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 225 225
2015 417 417
2016 284 284
2017 1873 1873
2018 1180 1180
2019 1167 1167
2020 1370 1370
2021 1387 1387
2022 1280 1280
2023 1162 1162
2024 514 514

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 1044 1044
Difficult to Insert 718 718
Product Quality Problem 697 697
Adverse Event Without Identified Device or Use Problem 583 583
Component Missing 552 552
Difficult to Remove 545 545
Material Twisted/Bent 544 544
Deflation Problem 533 533
Material Integrity Problem 474 474
Improper Chemical Reaction 401 401
Device Operates Differently Than Expected 391 391
Nonstandard Device 369 369
Incorrect Measurement 344 344
Short Fill 334 334
Fluid/Blood Leak 295 295
Break 255 255
Component Misassembled 254 254
Decrease in Pressure 253 253
Device Damaged Prior to Use 232 232
Misassembled 212 212
Patient-Device Incompatibility 187 187
Leak/Splash 181 181
Material Puncture/Hole 175 175
Partial Blockage 172 172
Material Rupture 170 170
Material Deformation 160 160
Sharp Edges 143 143
Device Misassembled During Manufacturing /Shipping 135 135
Failure to Infuse 130 130
Inadequacy of Device Shape and/or Size 125 125
Biocompatibility 122 122
Bent 118 118
Contamination /Decontamination Problem 111 111
Defective Device 109 109
Material Fragmentation 107 107
Scratched Material 106 106
Inaccurate Flow Rate 105 105
Insufficient Information 100 100
Material Too Rigid or Stiff 96 96
No Flow 94 94
Defective Component 92 92
Inflation Problem 91 91
Material Split, Cut or Torn 91 91
Device Contamination with Chemical or Other Material 91 91
Packaging Problem 85 85
Unsealed Device Packaging 78 78
Tear, Rip or Hole in Device Packaging 77 77
Material Protrusion/Extrusion 72 72
Difficult to Open or Remove Packaging Material 70 70
Failure to Align 70 70
Manufacturing, Packaging or Shipping Problem 64 64
Patient Device Interaction Problem 64 64
Device Handling Problem 60 60
Failure to Advance 58 58
Inability to Irrigate 58 58
Device Slipped 57 57
Moisture or Humidity Problem 50 50
Device Packaging Compromised 50 50
Appropriate Term/Code Not Available 48 48
Use of Device Problem 48 48
Device Fell 47 47
Obstruction of Flow 46 46
Detachment of Device or Device Component 46 46
Deformation Due to Compressive Stress 44 44
Improper or Incorrect Procedure or Method 43 43
Material Separation 42 42
Therapeutic or Diagnostic Output Failure 38 38
Physical Resistance/Sticking 33 33
Device Dislodged or Dislocated 33 33
Hole In Material 33 33
Device Contaminated During Manufacture or Shipping 30 30
Device Markings/Labelling Problem 29 29
Positioning Problem 29 29
Unintended Deflation 29 29
Failure to Deflate 28 28
Difficult to Advance 27 27
Fracture 27 27
Sticking 27 27
Incomplete or Missing Packaging 27 27
Structural Problem 25 25
Naturally Worn 24 24
Out-Of-Box Failure 23 23
Device Inoperable 22 22
Malposition of Device 22 22
Inadequate Instructions for Healthcare Professional 21 21
Filling Problem 21 21
Disconnection 21 21
Illegible Information 21 21
Infusion or Flow Problem 20 20
Restricted Flow rate 20 20
Mechanical Problem 20 20
Peeled/Delaminated 20 20
Contamination 19 19
Crack 19 19
Material Too Soft/Flexible 19 19
Physical Property Issue 18 18
Degraded 18 18
Delivered as Unsterile Product 18 18
Detachment Of Device Component 17 17
Cut In Material 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3401 3401
No Known Impact Or Consequence To Patient 3012 3013
No Consequences Or Impact To Patient 2246 2246
Urinary Tract Infection 799 800
Pain 685 685
No Patient Involvement 667 667
Hemorrhage/Bleeding 445 445
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 398 398
No Information 386 387
Patient Problem/Medical Problem 356 356
Discomfort 339 340
Blood Loss 141 141
Hematuria 126 126
No Code Available 116 116
Unspecified Infection 105 105
Urinary Retention 95 95
Foreign Body In Patient 82 82
Irritation 73 73
Bacterial Infection 60 60
Insufficient Information 59 59
Injury 39 39
Tissue Damage 35 35
Burning Sensation 31 31
Sepsis 26 26
Abdominal Pain 25 25
Abrasion 25 25
Device Embedded In Tissue or Plaque 24 24
Abdominal Distention 24 24
Laceration(s) 22 22
Skin Inflammation/ Irritation 22 22
Tissue Breakdown 21 21
Fever 20 20
Perforation 18 18
Swelling 16 16
Skin Irritation 14 14
Inadequate Pain Relief 13 13
Bruise/Contusion 13 13
Incontinence 12 12
Inflammation 11 11
Death 11 11
Alteration In Body Temperature 11 11
Irritability 11 11
Obstruction/Occlusion 11 11
Swelling/ Edema 11 11
Exposure to Body Fluids 10 10
Fistula 10 10
Hypersensitivity/Allergic reaction 10 10
High Blood Pressure/ Hypertension 9 9
Internal Organ Perforation 9 9
Renal Failure 9 9
Dysuria 9 9
Complaint, Ill-Defined 9 9
Anxiety 9 9
Chills 8 8
Urinary Frequency 7 7
Cancer 7 7
Skin Tears 7 7
Septic Shock 7 7
Skin Discoloration 7 7
Low Blood Pressure/ Hypotension 7 7
Itching Sensation 7 7
Hematoma 7 7
Unspecified Tissue Injury 7 7
Urinary Incontinence 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Unspecified Gastrointestinal Problem 6 6
Muscle Spasm(s) 6 6
Rash 6 6
Nausea 5 5
Erosion 4 4
Abscess 4 4
Distress 4 4
Fungal Infection 4 4
Genital Bleeding 4 4
Reaction 3 3
Pseudoaneurysm 3 3
Test Result 3 3
Anemia 3 3
Chest Pain 3 3
Erythema 3 3
Hyperglycemia 3 3
Micturition Urgency 3 3
Headache 3 3
Diarrhea 3 3
Dyspnea 3 3
Pneumonia 3 3
Pneumothorax 2 2
Local Reaction 2 2
Increased Sensitivity 2 2
Scar Tissue 2 2
Myocardial Infarction 2 2
Emotional Changes 2 2
Cardiac Arrest 2 2
Confusion/ Disorientation 2 2
Abdominal Cramps 2 2
Respiratory Failure 2 2
Post Operative Wound Infection 2 2
Extubate 2 2
Impaired Healing 2 2
Pressure Sores 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-11-2012
2 Boston Scientific Corporation II Jan-21-2010
3 C.R. Bard Inc II Feb-24-2022
4 C.R. Bard, Inc. II Apr-16-2021
5 C.R. Bard, Inc. II Sep-03-2015
6 C.R. Bard, Inc. II Aug-14-2015
7 C.R. Bard, Inc., Urological Division II Oct-04-2012
8 COVIDIEN LLC II Sep-20-2018
9 Cardinal Health 200, LLC I Feb-16-2024
10 ConvaTec, Inc II Mar-21-2019
11 Convatec Inc. II Mar-20-2014
12 Covidien Llc II May-14-2020
13 Nurse Assist, Inc II Jan-11-2012
14 Nurse Assist, Inc II May-25-2011
15 Rochester Medical Corp II Mar-16-2009
16 TELEFLEX LLC II Nov-11-2022
17 Teleflex Medical II Jul-26-2019
18 Teleflex Medical II Dec-16-2016
19 Teleflex Medical II Sep-18-2014
20 Teleflex Medical II Jun-09-2014
21 Teleflex Medical II Aug-03-2011
22 Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN II Jan-25-2011
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