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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 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
MEDLINE INDUSTRIES, 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
2018 1180 1180
2019 1167 1167
2020 1370 1370
2021 1387 1387
2022 1280 1280
2023 772 772

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 850 850
Material Twisted/Bent 484 484
Adverse Event Without Identified Device or Use Problem 468 468
Difficult to Remove 448 448
Difficult to Insert 447 447
Product Quality Problem 427 427
Improper Chemical Reaction 367 367
Deflation Problem 359 359
Short Fill 312 312
Incorrect Measurement 306 306
Nonstandard Device 297 297
Component Missing 282 282
Material Integrity Problem 230 230
Fluid/Blood Leak 219 219
Component Misassembled 219 219
Decrease in Pressure 218 218
Misassembled 208 208
Device Damaged Prior to Use 194 194
Patient-Device Incompatibility 139 139
Break 138 138
Partial Blockage 132 132
Material Rupture 132 132
Biocompatibility 122 122
Sharp Edges 121 121
Material Puncture/Hole 110 110
Contamination /Decontamination Problem 109 109
Failure to Infuse 106 106
Material Deformation 101 101
Inadequacy of Device Shape and/or Size 96 96
Inaccurate Flow Rate 94 94
Material Fragmentation 89 89
Leak/Splash 86 86
Material Split, Cut or Torn 82 82
Scratched Material 74 74
Material Too Rigid or Stiff 68 68
Defective Device 62 62
Patient Device Interaction Problem 59 59
No Flow 54 54
Device Slipped 52 52
Device Contamination with Chemical or Other Material 49 49
Device Fell 47 47
Packaging Problem 46 46
Material Protrusion/Extrusion 46 46
Tear, Rip or Hole in Device Packaging 46 46
Difficult to Open or Remove Packaging Material 45 45
Inflation Problem 45 45
Device Handling Problem 45 45
Device Operates Differently Than Expected 43 43
Inability to Irrigate 42 42
Manufacturing, Packaging or Shipping Problem 41 41
Detachment of Device or Device Component 40 40
Use of Device Problem 40 40
Obstruction of Flow 39 39
Deformation Due to Compressive Stress 38 38
Defective Component 37 37
Appropriate Term/Code Not Available 36 36
Therapeutic or Diagnostic Output Failure 36 36
Physical Resistance/Sticking 32 32
Bent 29 29
Failure to Align 28 28
Material Separation 27 27
Device Contaminated During Manufacture or Shipping 26 26
Device Dislodged or Dislocated 25 25
Fracture 24 24
Device Misassembled During Manufacturing /Shipping 22 22
Naturally Worn 22 22
Illegible Information 21 21
Device Markings/Labelling Problem 21 21
Inadequate Instructions for Healthcare Professional 20 20
Moisture or Humidity Problem 20 20
Insufficient Information 20 20
Material Too Soft/Flexible 19 19
Failure to Deflate 19 19
Peeled/Delaminated 19 19
Incomplete or Missing Packaging 18 18
Positioning Problem 18 18
Disconnection 17 17
Restricted Flow rate 16 16
Improper or Incorrect Procedure or Method 16 16
Structural Problem 15 15
Calcified 15 15
Unintended Deflation 15 15
Missing Information 14 14
Malposition of Device 14 14
Shipping Damage or Problem 13 13
Infusion or Flow Problem 13 13
Filling Problem 13 13
Gel Leak 13 13
Complete Blockage 12 12
Contamination 12 12
Crack 11 11
Material Invagination 11 11
Failure to Advance 9 9
Dent in Material 9 9
Fitting Problem 8 8
Mechanical Problem 8 8
Unsealed Device Packaging 8 8
Off-Label Use 8 8
Entrapment of Device 8 8
Physical Property Issue 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2732 2732
No Consequences Or Impact To Patient 1994 1994
No Known Impact Or Consequence To Patient 1718 1718
Urinary Tract Infection 542 542
No Patient Involvement 536 536
Pain 490 490
Patient Problem/Medical Problem 355 355
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 334 334
Hemorrhage/Bleeding 243 243
Discomfort 204 204
Blood Loss 92 92
Hematuria 91 91
No Code Available 66 66
Foreign Body In Patient 65 65
Unspecified Infection 62 62
No Information 60 61
Bacterial Infection 53 53
Insufficient Information 49 49
Irritation 37 37
Urinary Retention 36 36
Abrasion 20 20
Skin Inflammation/ Irritation 19 19
Tissue Damage 17 17
Sepsis 17 17
Tissue Breakdown 15 15
Abdominal Distention 14 14
Injury 14 14
Perforation 12 12
Abdominal Pain 12 12
Bruise/Contusion 11 11
Incontinence 11 11
Obstruction/Occlusion 11 11
Irritability 10 10
Device Embedded In Tissue or Plaque 10 10
Fistula 10 10
Skin Irritation 9 9
Swelling 9 9
Renal Failure 9 9
Burning Sensation 8 8
Laceration(s) 7 7
Cancer 7 7
Anxiety 7 7
Unspecified Gastrointestinal Problem 6 6
Urinary Incontinence 6 6
Swelling/ Edema 6 6
Septic Shock 6 6
Skin Discoloration 6 6
High Blood Pressure/ Hypertension 6 6
Inflammation 5 5
Fever 5 5
Skin Tears 5 5
Dysuria 4 4
Unspecified Tissue Injury 4 4
Itching Sensation 4 4
Internal Organ Perforation 4 4
Hypersensitivity/Allergic reaction 3 3
Death 3 3
Abscess 3 3
Chest Pain 2 2
Erythema 2 2
Headache 2 2
Chills 2 2
Vomiting 2 2
Rupture 2 2
Urinary Frequency 2 2
Pressure Sores 2 2
Scar Tissue 2 2
Pneumothorax 2 2
Rash 2 2
Local Reaction 2 2
Muscle Spasm(s) 2 2
Genital Bleeding 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Test Result 2 2
Pseudoaneurysm 2 2
Respiratory Failure 2 2
Distress 2 2
Fungal Infection 2 2
Post Operative Wound Infection 2 2
Diaphoresis 1 1
Prolapse 1 1
Skin Inflammation 1 1
Sweating 1 1
Confusion/ Disorientation 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Respiratory Insufficiency 1 1
Kidney Infection 1 1
Muscle Weakness 1 1
Nausea 1 1
Liver Damage/Dysfunction 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Scarring 1 1
Therapeutic Effects, Unexpected 1 1
Joint Swelling 1 1
Malaise 1 1
Inadequate Pain Relief 1 1
Laceration(s) of Esophagus 1 1
Extubate 1 1
Mediastinal Shift 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Feb-24-2022
2 C.R. Bard, Inc. II Apr-16-2021
3 COVIDIEN LLC II Sep-20-2018
4 ConvaTec, Inc II Mar-21-2019
5 Covidien Llc II May-14-2020
6 TELEFLEX LLC II Nov-11-2022
7 Teleflex Medical II Jul-26-2019
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