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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
AMSINO INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
APOLLON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSORS INTERNATIONAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
EMMY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
FLUME CATHETER COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU PRIMECARE MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HR PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NELLIE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PATHWAY, LLC
  SUBSTANTIALLY EQUIVALENT 2
POIESIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
POTRERO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
SAFE MEDICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 1
SILQ TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
2018 677 677
2019 670 670
2020 711 711
2021 701 701
2022 885 885
2023 507 507

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 556 556
Deflation Problem 539 539
Fluid/Blood Leak 536 536
Material Puncture/Hole 254 254
Difficult to Remove 253 253
Break 253 253
Leak/Splash 225 225
Decrease in Pressure 209 209
Material Invagination 180 180
Material Rupture 152 152
Material Split, Cut or Torn 131 131
Inflation Problem 123 123
Partial Blockage 122 122
Adverse Event Without Identified Device or Use Problem 119 119
Erratic or Intermittent Display 107 107
Failure to Infuse 97 97
Device Dislodged or Dislocated 90 90
Device Fell 74 74
Inaccurate Flow Rate 71 71
Component Missing 70 70
Material Fragmentation 65 65
Detachment of Device or Device Component 59 59
Material Deformation 58 58
Device Slipped 51 51
Obstruction of Flow 46 46
Material Integrity Problem 42 42
Patient-Device Incompatibility 40 40
Device Contamination with Chemical or Other Material 39 39
No Flow 39 39
Patient Device Interaction Problem 36 36
Component Misassembled 35 35
Incorrect Measurement 34 34
Physical Resistance/Sticking 33 33
Material Twisted/Bent 31 31
Difficult to Insert 30 30
Material Protrusion/Extrusion 29 29
Failure to Deflate 28 28
Tear, Rip or Hole in Device Packaging 27 27
Unintended Deflation 25 25
Insufficient Information 25 25
Dent in Material 24 24
Fracture 24 24
Hole In Material 23 23
Device Damaged Prior to Use 23 23
Mushroomed 22 22
Biocompatibility 21 21
Temperature Problem 20 20
Deformation Due to Compressive Stress 19 19
Calcified 18 18
Component Falling 18 18
No Display/Image 17 17
Material Perforation 17 17
Complete Blockage 16 16
Misassembled 15 15
Inadequate Instructions for Healthcare Professional 14 14
Short Fill 14 14
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Difficult to Advance 14 14
Infusion or Flow Problem 13 13
Gas/Air Leak 13 13
Defective Device 13 13
Crack 13 13
Restricted Flow rate 13 13
Detachment Of Device Component 12 12
Material Discolored 12 12
Low Readings 12 12
Device Operates Differently Than Expected 12 12
Sharp Edges 12 12
Appropriate Term/Code Not Available 11 11
Use of Device Problem 10 10
Off-Label Use 10 10
Inadequacy of Device Shape and/or Size 9 9
Disconnection 9 9
Therapeutic or Diagnostic Output Failure 9 9
Scratched Material 9 9
Gel Leak 8 8
Product Quality Problem 8 8
Nonstandard Device 8 8
Fitting Problem 8 8
High Readings 8 8
Contamination /Decontamination Problem 8 8
Device Markings/Labelling Problem 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Material Too Rigid or Stiff 7 7
Contamination 7 7
Material Separation 6 6
Defective Component 6 6
Device Displays Incorrect Message 6 6
Split 6 6
Failure to Advance 6 6
Improper Flow or Infusion 6 6
Output Problem 6 6
Blocked Connection 6 6
Missing Information 6 6
Device Sensing Problem 5 5
Inability to Irrigate 5 5
Collapse 4 4
Filling Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1727 1727
No Consequences Or Impact To Patient 1232 1232
No Known Impact Or Consequence To Patient 1045 1045
Pain 248 248
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 154 154
No Patient Involvement 151 151
Insufficient Information 133 133
Urinary Tract Infection 108 108
No Information 99 99
Patient Problem/Medical Problem 72 72
Discomfort 66 66
Hemorrhage/Bleeding 64 64
Hematuria 58 58
Foreign Body In Patient 57 57
No Code Available 42 42
Urinary Retention 39 39
Blood Loss 27 27
Unspecified Infection 23 23
Injury 13 13
Genital Bleeding 12 12
Skin Inflammation/ Irritation 12 12
Device Embedded In Tissue or Plaque 9 9
Tissue Damage 9 9
Burning Sensation 9 9
Inflammation 7 7
Sepsis 7 7
Fever 7 7
Perforation 6 6
Skin Tears 6 6
Tissue Breakdown 6 6
Urinary Incontinence 6 6
Unspecified Tissue Injury 5 5
Irritation 5 5
Incontinence 5 5
Death 4 4
Local Reaction 4 4
Abdominal Cramps 4 4
Cancer 3 3
Thrombus 3 3
Sweating 3 3
Cellulitis 3 3
Abrasion 3 3
Bacterial Infection 3 3
Laceration(s) 3 3
Muscle Spasm(s) 3 3
Skin Discoloration 3 3
Internal Organ Perforation 2 2
Rash 2 2
Erosion 2 2
Fistula 2 2
High Blood Pressure/ Hypertension 2 2
Diaphoresis 2 2
Fungal Infection 2 2
Dizziness 2 2
Anxiety 2 2
Distress 2 2
Unspecified Gastrointestinal Problem 2 2
Unspecified Kidney or Urinary Problem 2 2
Alteration In Body Temperature 2 2
Dysuria 2 2
Swelling/ Edema 2 2
Alteration in Body Temperature 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Localized Skin Lesion 1 1
Not Applicable 1 1
Test Result 1 1
Discharge 1 1
Viral Infection 1 1
Urinary Frequency 1 1
Vomiting 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Ulceration 1 1
Irritability 1 1
Toxicity 1 1
Sedation 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Shaking/Tremors 1 1
Sleep Dysfunction 1 1
Burn, Thermal 1 1
Chemical Exposure 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Failure of Implant 1 1
Headache 1 1
Hematoma 1 1
Abscess 1 1
Anemia 1 1
Stroke/CVA 1 1
Edema 1 1
Fatigue 1 1
Pulmonary Dysfunction 1 1
Skin Irritation 1 1
Tachycardia 1 1
Nausea 1 1
Abdominal Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Sep-23-2021
2 Degania Medical Devices Pvt. Ltd. II Apr-23-2020
3 Degania Silicone, Ltd. II Jan-13-2020
4 Degania Silicone, Ltd. II Sep-20-2018
5 Medline Industries Inc II May-18-2020
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