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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device stent, ureteral
Product CodeFAD
Regulation Number 876.4620
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 3
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
DORNIER MEDTECH AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCAMED SAM
  SUBSTANTIALLY EQUIVALENT 1
URETERAL STENT COMPANY
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 261 261
2020 352 352
2021 531 531
2022 559 559
2023 691 691
2024 183 183

Device Problems MDRs with this Device Problem Events in those MDRs
Break 500 500
Material Fragmentation 390 390
Calcified 230 230
Adverse Event Without Identified Device or Use Problem 218 218
Material Split, Cut or Torn 148 148
Difficult to Remove 144 144
Material Deformation 124 124
Migration 121 121
Material Separation 103 103
Difficult to Advance 101 101
Patient Device Interaction Problem 97 97
Detachment of Device or Device Component 93 93
Biocompatibility 91 91
Deformation Due to Compressive Stress 86 86
Fracture 46 46
Wrong Label 44 44
Device Dislodged or Dislocated 35 35
Material Twisted/Bent 33 33
Obstruction of Flow 33 33
Component Missing 30 30
Use of Device Problem 28 28
Difficult to Insert 26 26
Partial Blockage 25 25
Unsealed Device Packaging 21 21
Off-Label Use 21 21
Crack 19 19
Improper or Incorrect Procedure or Method 19 19
Device Damaged Prior to Use 19 19
Tear, Rip or Hole in Device Packaging 18 18
Entrapment of Device 18 18
Accessory Incompatible 18 18
Inadequate Instructions for Healthcare Professional 18 18
Material Integrity Problem 18 18
Complete Blockage 17 17
Device Contaminated During Manufacture or Shipping 16 16
Device Contamination with Chemical or Other Material 15 15
Component Misassembled 13 13
Material Too Rigid or Stiff 13 13
Incorrect Measurement 12 12
Nonstandard Device 12 12
Appropriate Term/Code Not Available 12 12
Device Handling Problem 11 11
Packaging Problem 11 11
Unraveled Material 11 11
Inaccurate Flow Rate 10 10
Device Markings/Labelling Problem 9 9
Device-Device Incompatibility 9 9
Failure to Advance 8 8
Flaked 8 8
Peeled/Delaminated 7 7
Defective Device 7 7
Activation, Positioning or Separation Problem 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Positioning Problem 6 6
Insufficient Information 6 6
Physical Resistance/Sticking 6 6
Material Rupture 6 6
Fluid/Blood Leak 6 6
Positioning Failure 6 6
Delivered as Unsterile Product 5 5
Migration or Expulsion of Device 5 5
Patient-Device Incompatibility 5 5
Activation Failure 5 5
No Flow 4 4
Device Fell 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Dent in Material 4 4
Defective Component 4 4
Disconnection 4 4
Material Puncture/Hole 3 3
Leak/Splash 3 3
Expiration Date Error 3 3
Device Damaged by Another Device 3 3
Separation Failure 3 3
Missing Information 3 3
No Apparent Adverse Event 3 3
Material Too Soft/Flexible 3 3
Contamination /Decontamination Problem 3 3
Material Protrusion/Extrusion 2 2
Improper Chemical Reaction 2 2
Infusion or Flow Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 2 2
Sharp Edges 2 2
Difficult or Delayed Separation 2 2
Premature Separation 2 2
Solder Joint Fracture 2 2
Stretched 2 2
Shipping Damage or Problem 2 2
Material Disintegration 2 2
Material Erosion 2 2
Component Incompatible 2 2
Contamination 2 2
Corroded 1 1
Biofilm coating in Device 1 1
Collapse 1 1
Failure to Discharge 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1500 1500
No Consequences Or Impact To Patient 327 327
No Known Impact Or Consequence To Patient 160 160
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 150 150
Pain 131 131
No Patient Involvement 83 83
Foreign Body In Patient 74 74
Insufficient Information 69 69
Urinary Tract Infection 56 56
Hematuria 51 51
Unspecified Infection 49 49
Discomfort 47 47
No Code Available 42 42
Obstruction/Occlusion 33 33
Unspecified Kidney or Urinary Problem 29 29
Hemorrhage/Bleeding 22 22
Micturition Urgency 21 21
Dysuria 20 20
Swelling/ Edema 19 19
Calcium Deposits/Calcification 17 17
Device Embedded In Tissue or Plaque 16 16
Fever 14 14
Fistula 13 13
Sepsis 13 13
Abdominal Pain 11 11
Post Operative Wound Infection 11 11
Patient Problem/Medical Problem 10 10
Urinary Frequency 10 10
Urinary Retention 10 10
Inflammation 9 9
Failure of Implant 9 9
Perforation 8 8
Renal Failure 7 7
Incontinence 6 6
Internal Organ Perforation 5 5
Swelling 5 5
No Information 4 4
Erosion 4 4
Bacterial Infection 4 4
Exposure to Body Fluids 3 3
Irritation 3 3
Occlusion 3 3
Irritability 3 3
Tachycardia 3 3
Injury 3 3
Urethral Stenosis/Stricture 3 3
Skin Inflammation/ Irritation 3 3
Urinary Incontinence 3 3
Kidney Infection 2 2
Reaction 2 2
Chills 2 2
Skin Discoloration 2 2
Nausea 2 2
Hypersensitivity/Allergic reaction 2 2
Death 2 2
Dyspnea 2 2
Edema 2 2
Extravasation 2 2
Abrasion 1 1
Abscess 1 1
Adhesion(s) 1 1
Low Blood Pressure/ Hypotension 1 1
Hematoma 1 1
Laceration(s) 1 1
Liver Damage/Dysfunction 1 1
Skin Erosion 1 1
Septic Shock 1 1
Shock 1 1
Pleural Effusion 1 1
Skin Inflammation 1 1
Respiratory Failure 1 1
Ascites 1 1
Blood Loss 1 1
Thrombosis/Thrombus 1 1
Renal Impairment 1 1
Intraoperative Pain 1 1
Tissue Breakdown 1 1
Fungal Infection 1 1
Impaired Healing 1 1
Urticaria 1 1
Vomiting 1 1
Burning Sensation 1 1
Infection, Pyrogenic 1 1
Peritonitis 1 1
Stenosis 1 1
Vesicovaginal Fistula 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Dec-30-2020
2 Cook Inc. II Feb-05-2021
3 Cook Inc. II Sep-15-2020
4 Cook Inc. II Feb-04-2020
5 Hobbs Medical, Inc. II Oct-07-2022
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