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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 3
APOLLON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSORS INTERNATIONAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU RONGXIN MEDICINE MINIMAL INVASION TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK UROLOGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COVALON TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
EMMY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
FLUME CATHETER COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., 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
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NELLIE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PATHWAY, LLC
  SUBSTANTIALLY EQUIVALENT 2
PERCUVISION
  SUBSTANTIALLY EQUIVALENT 1
PERCUVISION LLC
  SUBSTANTIALLY EQUIVALENT 1
POIESIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
POTRERO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 2
SAFE MEDICAL DESIGN
  SUBSTANTIALLY EQUIVALENT 1
SEEDINGS LIFE SCIENCE VENTURES, LLC
  SUBSTANTIALLY EQUIVALENT 2
SENTINEL MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SILQ TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SILQ TECHNOLOGIES, CORP.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
THE FLUME CATHETER COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
URETHROTECH
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO. LTD
  SUBSTANTIALLY EQUIVALENT 2
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 229 229
2015 303 303
2016 326 326
2017 571 571
2018 677 677
2019 670 670
2020 711 711
2021 701 701
2022 884 884
2023 776 776
2024 674 674

Device Problems MDRs with this Device Problem Events in those MDRs
Deflation Problem 870 870
Burst Container or Vessel 870 870
Fluid/Blood Leak 641 641
Difficult to Remove 429 429
Material Puncture/Hole 369 369
Break 360 360
Leak/Splash 326 326
Material Rupture 252 252
Decrease in Pressure 237 237
Inflation Problem 220 220
Material Invagination 216 216
Material Split, Cut or Torn 166 166
Partial Blockage 146 146
Device Dislodged or Dislocated 144 144
Adverse Event Without Identified Device or Use Problem 129 129
Material Deformation 125 125
Failure to Infuse 118 118
Erratic or Intermittent Display 113 113
Component Missing 100 100
Material Fragmentation 96 96
Device Operates Differently Than Expected 92 92
Inaccurate Flow Rate 88 88
Mushroomed 87 87
Material Integrity Problem 75 75
Device Fell 74 74
Device Contamination with Chemical or Other Material 74 74
Hole In Material 70 70
No Flow 67 67
Detachment of Device or Device Component 66 66
Failure to Deflate 62 62
Obstruction of Flow 59 59
Device Slipped 58 58
Component Falling 51 51
Material Protrusion/Extrusion 49 49
Unintended Deflation 49 49
Component Misassembled 46 46
Fracture 43 43
Patient-Device Incompatibility 43 43
Defective Device 41 41
Insufficient Information 39 39
Patient Device Interaction Problem 39 39
Incorrect Measurement 39 39
Difficult to Insert 39 39
Physical Resistance/Sticking 36 36
Material Twisted/Bent 34 34
Detachment Of Device Component 34 34
Crack 31 31
Tear, Rip or Hole in Device Packaging 31 31
Complete Blockage 30 30
Appropriate Term/Code Not Available 29 29

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2428 2428
No Known Impact Or Consequence To Patient 1678 1678
No Consequences Or Impact To Patient 1563 1563
Pain 389 389
No Patient Involvement 233 233
No Information 216 216
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 212 212
Insufficient Information 210 210
Urinary Tract Infection 141 141
Discomfort 135 135
Hemorrhage/Bleeding 97 97
Urinary Retention 92 92
Foreign Body In Patient 83 83
Hematuria 77 77
Patient Problem/Medical Problem 72 72
No Code Available 62 62
Blood Loss 34 34
Unspecified Infection 28 28
Injury 28 28
Device Embedded In Tissue or Plaque 21 21
Genital Bleeding 15 15
Burning Sensation 13 13
Skin Inflammation/ Irritation 13 13
Tissue Damage 12 12
Inflammation 9 9
Fever 8 8
Irritation 8 8
Death 7 7
Sepsis 7 7
Perforation 6 6
Urinary Incontinence 6 6
Unspecified Tissue Injury 6 6
Skin Tears 6 6
Erosion 6 6
Tissue Breakdown 6 6
Laceration(s) 5 5
Exposure to Body Fluids 5 5
Alteration In Body Temperature 5 5
Incontinence 5 5
Anxiety 4 4
Abdominal Cramps 4 4
Abdominal Distention 4 4
Swelling 4 4
Muscle Spasm(s) 4 4
Local Reaction 4 4
Internal Organ Perforation 4 4
Hypersensitivity/Allergic reaction 4 4
Abdominal Pain 4 4
Unspecified Kidney or Urinary Problem 3 3
Scar Tissue 3 3

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Sep-23-2021
2 C.R. Bard, Inc. II Sep-15-2016
3 Cardinal Health 200, LLC I Feb-16-2024
4 Coloplast Manufacturing US, LLC II Apr-20-2016
5 Covidien LLC II Mar-21-2016
6 Degania Medical Devices Pvt. Ltd. II Apr-23-2020
7 Degania Silicone, Ltd. II Jan-13-2020
8 Degania Silicone, Ltd. II Sep-20-2018
9 Medline Industries Inc II May-18-2020
10 Nurse Assist, LLC I Dec-20-2023
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