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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 catheter, retention type, balloon
Regulation Description Urological catheter and accessories.
Product CodeEZL
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
APOLLON CO., 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
INNOCARE UROLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PATHWAY, LLC
  SUBSTANTIALLY EQUIVALENT 1
POTRERO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 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 2
THE FLUME CATHETER COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 711 711
2021 701 701
2022 884 884
2023 776 776
2024 1038 1038
2025 551 551

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 572 572
Material Puncture/Hole 491 491
Fluid/Blood Leak 399 399
Difficult to Remove 273 273
Material Rupture 271 271
Deflation Problem 250 250
Decrease in Pressure 237 237
Material Invagination 183 183
Material Split, Cut or Torn 179 179
Material Fragmentation 124 124
Adverse Event Without Identified Device or Use Problem 122 122
Break 119 119
Partial Blockage 119 119
Inflation Problem 109 109
Erratic or Intermittent Display 101 101
Leak/Splash 87 87
Failure to Deflate 84 84
Failure to Infuse 82 82
Inaccurate Flow Rate 66 66
Component Missing 65 65
Device Contamination with Chemical or Other Material 58 58
Component Misassembled 57 57
Unintended Deflation 54 54
Fracture 47 47
Patient Device Interaction Problem 43 43
Obstruction of Flow 40 40
Device Fell 39 39
Device Dislodged or Dislocated 37 37
Device Slipped 35 35
Detachment of Device or Device Component 35 35
Wrong Label 34 34
Insufficient Information 33 33
Device Contaminated During Manufacture or Shipping 32 32
Material Integrity Problem 31 31
Appropriate Term/Code Not Available 29 29
Deformation Due to Compressive Stress 29 29
Incorrect Measurement 29 29
Material Twisted/Bent 28 28
Material Protrusion/Extrusion 28 28
No Flow 27 27
Dent in Material 26 26
Difficult to Insert 25 25
Material Deformation 25 25
Calcified 24 24
Biocompatibility 22 22
Physical Resistance/Sticking 22 22
Tear, Rip or Hole in Device Packaging 22 22
Short Fill 22 22
Complete Blockage 20 20
Material Separation 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3123 3123
No Consequences Or Impact To Patient 480 480
No Known Impact Or Consequence To Patient 270 270
Insufficient Information 256 256
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 251 251
Pain 243 243
Urinary Tract Infection 128 128
Discomfort 99 99
Hematuria 72 72
Foreign Body In Patient 67 67
Urinary Retention 64 64
No Patient Involvement 49 49
Hemorrhage/Bleeding 48 48
Patient Problem/Medical Problem 28 28
Unspecified Infection 18 18
Skin Inflammation/ Irritation 17 17
Genital Bleeding 16 16
No Code Available 12 12
Sepsis 12 12
Exposure to Body Fluids 11 11
Blood Loss 9 9
No Information 9 9
Unspecified Tissue Injury 8 8
Device Embedded In Tissue or Plaque 7 7
Tissue Breakdown 6 6
Urinary Incontinence 6 6
Incontinence 6 6
Perforation 6 6
Injury 6 6
Skin Tears 6 6
Cramp(s) /Muscle Spasm(s) 5 5
Fistula 5 5
Fever 5 5
Burning Sensation 5 5
Unspecified Kidney or Urinary Problem 4 4
Death 4 4
Pressure Sores 4 4
Inflammation 4 4
Cancer 4 4
Internal Organ Perforation 4 4
Distress 4 4
Micturition Urgency 3 3
Kidney Infection 3 3
Cellulitis 3 3
Erosion 3 3
Anemia 3 3
Abrasion 3 3
Dizziness 3 3
Ulcer 3 3
Skin Discoloration 3 3

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 Coloplast Manufacturing US, LLC II Jan-10-2025
4 Degania Medical Devices Pvt. Ltd. II Apr-23-2020
5 Degania Silicone, Ltd. II Jan-13-2020
6 Medline Industries Inc II May-18-2020
7 Nurse Assist, LLC I Dec-20-2023
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