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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 323 323

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 564 564
Material Puncture/Hole 430 430
Fluid/Blood Leak 371 371
Difficult to Remove 264 264
Deflation Problem 242 242
Material Rupture 238 238
Decrease in Pressure 237 237
Material Invagination 179 179
Material Split, Cut or Torn 165 165
Adverse Event Without Identified Device or Use Problem 121 121
Break 119 119
Partial Blockage 118 118
Material Fragmentation 113 113
Erratic or Intermittent Display 101 101
Inflation Problem 91 91
Leak/Splash 84 84
Failure to Infuse 82 82
Failure to Deflate 81 81
Inaccurate Flow Rate 64 64
Component Missing 63 63
Device Contamination with Chemical or Other Material 56 56
Component Misassembled 54 54
Unintended Deflation 53 53
Fracture 46 46
Patient Device Interaction Problem 42 42
Obstruction of Flow 40 40
Device Fell 39 39
Device Slipped 34 34
Device Dislodged or Dislocated 33 33
Detachment of Device or Device Component 33 33
Device Contaminated During Manufacture or Shipping 32 32
Insufficient Information 31 31
Wrong Label 31 31
Material Integrity Problem 30 30
Incorrect Measurement 28 28
Material Twisted/Bent 28 28
Material Protrusion/Extrusion 27 27
Deformation Due to Compressive Stress 27 27
No Flow 26 26
Dent in Material 26 26
Material Deformation 25 25
Appropriate Term/Code Not Available 24 24
Calcified 24 24
Difficult to Insert 24 24
Tear, Rip or Hole in Device Packaging 22 22
Physical Resistance/Sticking 22 22
Short Fill 22 22
Biocompatibility 22 22
Complete Blockage 20 20
Gel Leak 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2940 2940
No Consequences Or Impact To Patient 480 480
No Known Impact Or Consequence To Patient 270 270
Insufficient Information 254 254
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 238 238
Pain 229 229
Urinary Tract Infection 127 127
Discomfort 96 96
Hematuria 66 66
Foreign Body In Patient 64 64
Urinary Retention 64 64
No Patient Involvement 49 49
Hemorrhage/Bleeding 44 44
Patient Problem/Medical Problem 28 28
Unspecified Infection 18 18
Skin Inflammation/ Irritation 16 16
Genital Bleeding 15 15
Sepsis 12 12
No Code Available 12 12
Blood Loss 9 9
No Information 9 9
Exposure to Body Fluids 8 8
Device Embedded In Tissue or Plaque 7 7
Unspecified Tissue Injury 7 7
Urinary Incontinence 6 6
Skin Tears 6 6
Injury 6 6
Perforation 6 6
Incontinence 6 6
Tissue Breakdown 6 6
Burning Sensation 5 5
Fever 5 5
Fistula 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Pressure Sores 4 4
Cancer 4 4
Inflammation 4 4
Unspecified Kidney or Urinary Problem 4 4
Death 4 4
Internal Organ Perforation 4 4
Kidney Infection 3 3
Rash 3 3
Distress 3 3
Septic Shock 3 3
Skin Discoloration 3 3
Cellulitis 3 3
Sweating 3 3
Laceration(s) 3 3
Local Reaction 3 3
Anemia 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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