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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 3
  SUBSTANTIALLY EQUIVALENT - KIT 3
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT - KIT 2
  SUBSTANTIALLY EQUIVALENT 5
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 4
  SUBSTANTIALLY EQUIVALENT 7
DORNIER MEDTECH AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
PROMEPLA SAM
  SUBSTANTIALLY EQUIVALENT 1
Q UROLOGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROCAMED SAM
  SUBSTANTIALLY EQUIVALENT 1
URETERAL STENT COMPANY
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 265 265
2018 277 277
2019 261 261
2020 352 352
2021 531 531
2022 559 559
2023 691 691
2024 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Break 688 688
Material Fragmentation 383 383
Calcified 286 286
Adverse Event Without Identified Device or Use Problem 229 229
Difficult to Remove 195 195
Material Split, Cut or Torn 154 154
Material Deformation 133 133
Migration 127 127
Material Separation 127 127
Detachment of Device or Device Component 99 99
Biocompatibility 98 98
Difficult to Advance 96 96
Patient Device Interaction Problem 95 95
Deformation Due to Compressive Stress 84 84
Fracture 67 67
Device Damaged Prior to Use 61 61
Wrong Label 43 43
Device Dislodged or Dislocated 37 37
Obstruction of Flow 37 37
Component Missing 35 35
Material Twisted/Bent 33 33
Partial Blockage 32 32
Use of Device Problem 30 30
Crack 27 27
Difficult to Insert 27 27
Tear, Rip or Hole in Device Packaging 26 26
Material Integrity Problem 24 24
Detachment Of Device Component 24 24
Unsealed Device Packaging 23 23
Off-Label Use 21 21
Torn Material 21 21
Device Contamination with Chemical or Other Material 21 21
Entrapment of Device 20 20
Improper or Incorrect Procedure or Method 19 19
Migration or Expulsion of Device 18 18
Inadequate Instructions for Healthcare Professional 18 18
Accessory Incompatible 18 18
Complete Blockage 17 17
Split 17 17
Appropriate Term/Code Not Available 16 16
Kinked 15 15
Material Too Rigid or Stiff 14 14
Device Contaminated During Manufacture or Shipping 14 14
Failure to Advance 13 13
Incorrect Measurement 13 13
Nonstandard Device 12 12
Unraveled Material 12 12
Device Operates Differently Than Expected 12 12
Packaging Problem 12 12
Component Misassembled 12 12
Out-Of-Box Failure 11 11
Stretched 10 10
Knotted 10 10
Flaked 10 10
Inaccurate Flow Rate 10 10
Device Handling Problem 10 10
Insufficient Information 10 10
Device Markings/Labelling Problem 9 9
Defective Device 9 9
Bent 9 9
Peeled/Delaminated 8 8
Activation, Positioning or Separation Problem 8 8
Device-Device Incompatibility 8 8
Positioning Problem 7 7
Physical Resistance/Sticking 7 7
Material Rupture 7 7
Defective Component 6 6
Positioning Failure 6 6
Fluid/Blood Leak 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Patient-Device Incompatibility 6 6
Expiration Date Error 6 6
No Flow 5 5
Activation Failure 5 5
Material Frayed 5 5
Delivered as Unsterile Product 5 5
Disconnection 4 4
Material Disintegration 4 4
Device Fell 4 4
Contamination /Decontamination Problem 4 4
Dent in Material 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Device Operational Issue 3 3
Device Damaged by Another Device 3 3
Device Packaging Compromised 3 3
Structural Problem 3 3
Separation Failure 3 3
Material Too Soft/Flexible 3 3
Missing Information 3 3
No Apparent Adverse Event 3 3
Leak/Splash 3 3
Occlusion Within Device 3 3
Incomplete or Missing Packaging 3 3
Product Quality Problem 3 3
Uncoiled 2 2
Failure to Unfold or Unwrap 2 2
Material Puncture/Hole 2 2
Shipping Damage or Problem 2 2
Material Erosion 2 2
Material Discolored 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1465 1465
No Consequences Or Impact To Patient 546 546
No Known Impact Or Consequence To Patient 354 354
No Patient Involvement 173 173
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 147 147
Pain 144 144
Foreign Body In Patient 92 92
No Code Available 73 73
Insufficient Information 67 67
Unspecified Infection 56 56
Urinary Tract Infection 56 56
Hematuria 53 53
Discomfort 47 47
Obstruction/Occlusion 33 33
No Information 30 30
Unspecified Kidney or Urinary Problem 29 29
Device Embedded In Tissue or Plaque 26 26
Hemorrhage/Bleeding 21 21
Micturition Urgency 21 21
Dysuria 20 20
Swelling/ Edema 19 19
Calcium Deposits/Calcification 17 17
Fever 15 15
Fistula 13 13
Sepsis 13 13
Patient Problem/Medical Problem 13 13
Urinary Retention 12 12
Abdominal Pain 12 12
Failure of Implant 11 11
Post Operative Wound Infection 11 11
Urinary Frequency 10 10
Inflammation 9 9
Perforation 9 9
Renal Failure 8 8
Incontinence 6 6
Internal Organ Perforation 6 6
Swelling 5 5
Injury 5 5
Bacterial Infection 5 5
Erosion 4 4
Occlusion 4 4
Nausea 3 3
Hypersensitivity/Allergic reaction 3 3
Irritation 3 3
Exposure to Body Fluids 3 3
Death 3 3
Edema 3 3
Irritability 3 3
Tachycardia 3 3
Urethral Stenosis/Stricture 3 3
Skin Inflammation/ Irritation 3 3
Urinary Incontinence 3 3
Kidney Infection 2 2
Skin Discoloration 2 2
Chills 2 2
Stenosis 2 2
Reaction 2 2
Extravasation 2 2
Dyspnea 2 2
Laceration(s) 2 2
Liver Damage/Dysfunction 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress 1 1
Pleural Effusion 1 1
Local Reaction 1 1
Headache 1 1
Hematoma 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abrasion 1 1
Abscess 1 1
Adhesion(s) 1 1
Awareness during Anaesthesia 1 1
Fungal Infection 1 1
Impaired Healing 1 1
Sore Throat 1 1
Respiratory Failure 1 1
Skin Inflammation 1 1
Intraoperative Pain 1 1
Tissue Breakdown 1 1
Alteration In Body Temperature 1 1
Concussion 1 1
Vomiting 1 1
Burning Sensation 1 1
Urticaria 1 1
Infection, Pyrogenic 1 1
Peritonitis 1 1
Skin Erosion 1 1
Septic Shock 1 1
Shock 1 1
Thrombosis/Thrombus 1 1
Renal Impairment 1 1
Vesicovaginal Fistula 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Infection 1 1
Ascites 1 1
Blood Loss 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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