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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, retention type, balloon
Product CodeEZL
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
APOLLON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSORS INTERNATIONAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1
FLUME CATHETER COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU PRIMECARE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HR PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PATHWAY, LLC
  SUBSTANTIALLY EQUIVALENT 1
POTRERO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
SAFE MEDICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 1
SENTINEL MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SILQ TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SILQ TECHNOLOGIES, CORP.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE FLUME CATHETER COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
URETHROTECH
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 670 670
2020 711 711
2021 701 701
2022 884 884
2023 775 775
2024 278 278

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 549 549
Fluid/Blood Leak 465 465
Deflation Problem 399 399
Material Puncture/Hole 288 288
Difficult to Remove 263 263
Decrease in Pressure 237 237
Material Invagination 183 183
Break 181 181
Material Rupture 157 157
Material Split, Cut or Torn 145 145
Leak/Splash 128 128
Partial Blockage 120 120
Adverse Event Without Identified Device or Use Problem 111 111
Erratic or Intermittent Display 103 103
Failure to Infuse 88 88
Inflation Problem 81 81
Material Fragmentation 79 79
Device Fell 68 68
Inaccurate Flow Rate 63 63
Device Dislodged or Dislocated 62 62
Component Missing 61 61
Failure to Deflate 50 50
Device Contamination with Chemical or Other Material 47 47
Detachment of Device or Device Component 46 46
Device Slipped 46 46
Obstruction of Flow 45 45
Material Deformation 41 41
Component Misassembled 39 39
Patient Device Interaction Problem 39 39
Unintended Deflation 36 36
Material Integrity Problem 35 35
Fracture 33 33
Physical Resistance/Sticking 32 32
No Flow 31 31
Incorrect Measurement 30 30
Material Twisted/Bent 27 27
Dent in Material 25 25
Material Protrusion/Extrusion 24 24
Difficult to Insert 24 24
Insufficient Information 23 23
Tear, Rip or Hole in Device Packaging 23 23
Patient-Device Incompatibility 23 23
Deformation Due to Compressive Stress 23 23
Biocompatibility 21 21
Appropriate Term/Code Not Available 20 20
Complete Blockage 19 19
Calcified 18 18
Short Fill 17 17
No Display/Image 15 15
Device Damaged Prior to Use 15 15
Material Perforation 14 14
Difficult to Advance 14 14
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Nonstandard Device 13 13
Temperature Problem 13 13
Low Readings 12 12
Off-Label Use 12 12
Misassembled 12 12
Inadequate Instructions for Healthcare Professional 12 12
Material Discolored 12 12
Gel Leak 11 11
Gas/Air Leak 11 11
Device Contaminated During Manufacture or Shipping 11 11
Sharp Edges 11 11
Contamination /Decontamination Problem 10 10
Infusion or Flow Problem 9 9
Defective Device 9 9
Therapeutic or Diagnostic Output Failure 9 9
Restricted Flow rate 9 9
Disconnection 9 9
Crack 9 9
Missing Information 9 9
Contamination 8 8
Material Too Rigid or Stiff 8 8
Scratched Material 8 8
Device Handling Problem 7 7
High Readings 7 7
Device Markings/Labelling Problem 7 7
Product Quality Problem 7 7
Inability to Irrigate 6 6
Use of Device Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Fitting Problem 6 6
Material Separation 6 6
Inadequacy of Device Shape and/or Size 6 6
Wrong Label 6 6
Delivered as Unsterile Product 5 5
Device Sensing Problem 5 5
Improper Flow or Infusion 5 5
Defective Component 5 5
Failure to Advance 5 5
Structural Problem 4 4
Incomplete or Missing Packaging 4 4
Blocked Connection 4 4
Migration 4 4
Material Too Soft/Flexible 4 4
Output Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Inadequate or Insufficient Training 4 4
Collapse 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2115 2115
No Consequences Or Impact To Patient 898 898
No Known Impact Or Consequence To Patient 662 662
Pain 218 218
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 192 192
Insufficient Information 178 178
Urinary Tract Infection 102 102
No Patient Involvement 90 90
Discomfort 70 70
Patient Problem/Medical Problem 60 60
Foreign Body In Patient 54 54
No Information 52 52
Hemorrhage/Bleeding 52 52
Hematuria 50 50
Urinary Retention 45 45
Unspecified Infection 20 20
Blood Loss 17 17
No Code Available 16 16
Genital Bleeding 14 14
Skin Inflammation/ Irritation 13 13
Device Embedded In Tissue or Plaque 8 8
Sepsis 7 7
Fever 7 7
Injury 7 7
Skin Tears 6 6
Perforation 6 6
Unspecified Tissue Injury 6 6
Urinary Incontinence 6 6
Tissue Breakdown 6 6
Inflammation 5 5
Incontinence 5 5
Laceration(s) 4 4
Internal Organ Perforation 4 4
Local Reaction 4 4
Exposure to Body Fluids 4 4
Death 4 4
Burning Sensation 4 4
Tissue Damage 3 3
Skin Discoloration 3 3
Sweating 3 3
Cellulitis 3 3
Abrasion 3 3
Necrosis 3 3
Muscle Spasm(s) 3 3
High Blood Pressure/ Hypertension 3 3
Cancer 3 3
Fluid Discharge 2 2
Alteration In Body Temperature 2 2
Chemical Exposure 2 2
Fungal Infection 2 2
Swelling/ Edema 2 2
Unspecified Kidney or Urinary Problem 2 2
Unspecified Gastrointestinal Problem 2 2
Failure of Implant 2 2
Irritation 2 2
Erosion 2 2
Fistula 2 2
Fatigue 2 2
Diaphoresis 2 2
Sleep Dysfunction 2 2
Anxiety 2 2
Distress 2 2
Rash 2 2
Dizziness 2 2
Vomiting 1 1
Discharge 1 1
Viral Infection 1 1
Urinary Frequency 1 1
Pressure Sores 1 1
Ulceration 1 1
Skin Irritation 1 1
Tachycardia 1 1
Thrombus 1 1
Toxicity 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Burn, Thermal 1 1
Abdominal Cramps 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Abdominal Pain 1 1
Hypersensitivity/Allergic reaction 1 1
Micturition Urgency 1 1
Headache 1 1
Hematoma 1 1
Bruise/Contusion 1 1
Anemia 1 1
Bacterial Infection 1 1
Stroke/CVA 1 1
Edema 1 1
Nausea 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Pulmonary Dysfunction 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Septic Shock 1 1
Kidney Infection 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Sep-23-2021
2 Cardinal Health 200, LLC I Feb-16-2024
3 Degania Medical Devices Pvt. Ltd. II Apr-23-2020
4 Degania Silicone, Ltd. II Jan-13-2020
5 Medline Industries Inc II May-18-2020
6 Nurse Assist, LLC I Dec-20-2023
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