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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, urological
Regulation Description Urological catheter and accessories.
Product CodeKOD
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
UROGEN PHARMA LTD
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1370 1370
2021 1387 1387
2022 1280 1280
2023 1162 1162
2024 1262 1262
2025 691 691

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 857 857
Improper Chemical Reaction 462 462
Adverse Event Without Identified Device or Use Problem 440 440
Difficult to Remove 436 436
Material Twisted/Bent 353 353
Device Misassembled During Manufacturing /Shipping 346 346
Material Rupture 338 338
Component Misassembled 324 324
Material Puncture/Hole 273 273
Decrease in Pressure 255 255
Deflation Problem 253 253
Sharp Edges 226 226
Incorrect Measurement 202 202
Fluid/Blood Leak 200 200
Difficult to Insert 189 189
Tear, Rip or Hole in Device Packaging 157 157
Partial Blockage 156 156
Short Fill 154 154
Nonstandard Device 136 136
Component Missing 128 128
Biocompatibility 121 121
Contamination /Decontamination Problem 111 111
Material Fragmentation 106 106
Inaccurate Flow Rate 104 104
Failure to Infuse 95 95
Material Split, Cut or Torn 94 94
Leak/Splash 75 75
Unsealed Device Packaging 72 72
Patient Device Interaction Problem 72 72
Material Too Rigid or Stiff 68 68
Device Handling Problem 65 65
Break 62 62
Product Quality Problem 60 60
Material Protrusion/Extrusion 55 55
Difficult to Open or Remove Packaging Material 52 52
Inflation Problem 47 47
Device Contamination with Chemical or Other Material 46 46
Unintended Deflation 43 43
Inability to Irrigate 42 42
Device Slipped 42 42
Inadequacy of Device Shape and/or Size 38 38
Deformation Due to Compressive Stress 35 35
Defective Device 35 35
Device Fell 34 34
Device Contaminated During Manufacture or Shipping 34 34
Incomplete or Missing Packaging 34 34
Material Separation 32 32
Failure to Deflate 31 31
Naturally Worn 29 29
Material Deformation 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4542 4542
No Consequences Or Impact To Patient 807 807
No Known Impact Or Consequence To Patient 469 469
Pain 460 460
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 451 451
Urinary Tract Infection 442 442
Discomfort 186 186
No Patient Involvement 181 181
Hemorrhage/Bleeding 101 101
Patient Problem/Medical Problem 93 93
Hematuria 87 87
Insufficient Information 68 68
Foreign Body In Patient 66 66
Blood Loss 63 63
Unspecified Tissue Injury 62 62
Unspecified Infection 55 55
Bacterial Infection 52 52
No Code Available 49 49
Urinary Retention 37 37
Sepsis 29 29
Abdominal Distention 28 28
Skin Inflammation/ Irritation 28 28
Tissue Breakdown 25 25
Swelling/ Edema 16 16
Perforation 16 16
Abrasion 15 15
Abdominal Pain 15 15
Exposure to Body Fluids 13 13
Bruise/Contusion 13 13
Irritability 12 12
Fever 11 11
Fistula 11 11
Incontinence 11 11
Irritation 11 11
Skin Discoloration 10 10
Burning Sensation 10 10
Obstruction/Occlusion 10 10
Inflammation 10 10
Laceration(s) 10 10
Dysuria 9 9
Micturition Urgency 8 8
Injury 8 8
Genital Bleeding 8 8
Cramp(s) /Muscle Spasm(s) 8 8
Urinary Incontinence 7 7
Hematoma 7 7
Septic Shock 7 7
Cancer 7 7
Low Blood Pressure/ Hypotension 6 6
Unspecified Gastrointestinal Problem 6 6

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Feb-24-2022
2 C.R. Bard, Inc. II Apr-16-2021
3 Cardinal Health 200, LLC I Feb-16-2024
4 Covidien Llc II May-14-2020
5 TELEFLEX LLC II Nov-11-2022
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