Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, urethral
Product CodeGBM
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
COLOPLAST
  SUBSTANTIALLY EQUIVALENT 6
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 3
COLOPLAST CORP.
  SUBSTANTIALLY EQUIVALENT 2
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
F&S MEDICAL SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAKKI MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU JIMUSHI MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER INCORPORATED
  SUBSTANTIALLY EQUIVALENT 8
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
ROBLING MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT - KIT 1
THINKMED MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 19 19
2015 20 20
2016 49 49
2017 59 59
2018 82 82
2019 148 148
2020 144 144
2021 102 102
2022 283 283
2023 202 202
2024 396 396

Device Problems MDRs with this Device Problem Events in those MDRs
Tear, Rip or Hole in Device Packaging 333 333
Adverse Event Without Identified Device or Use Problem 174 174
Device Misassembled During Manufacturing /Shipping 84 84
Break 73 73
Difficult to Open or Remove Packaging Material 65 65
Difficult to Remove 64 64
Sharp Edges 59 59
Delivered as Unsterile Product 54 54
Deflation Problem 47 47
Fluid/Blood Leak 42 42
Patient Device Interaction Problem 35 35
Biocompatibility 34 34
Material Puncture/Hole 34 34
Material Invagination 29 29
Partial Blockage 28 28
Burst Container or Vessel 28 28
Product Quality Problem 27 27
Material Deformation 26 26
Contamination /Decontamination Problem 25 25
Packaging Problem 24 24
Unsealed Device Packaging 21 21
Leak/Splash 19 19
Decrease in Pressure 19 19
Difficult to Insert 19 19
Insufficient Information 17 17
Material Split, Cut or Torn 17 17
Difficult to Open or Close 16 16
Device Damaged Prior to Use 15 15
Material Rupture 14 14
Device Handling Problem 13 13
Device Contamination with Chemical or Other Material 12 12
Device Markings/Labelling Problem 12 12
Material Too Rigid or Stiff 12 12
Inflation Problem 12 12
Detachment Of Device Component 10 10
Material Fragmentation 10 10
Inaccurate Flow Rate 10 10
Appropriate Term/Code Not Available 9 9
Entrapment of Device 9 9
Failure to Infuse 8 8
Defective Device 8 8
Detachment of Device or Device Component 8 8
Dent in Material 8 8
Device Operates Differently Than Expected 7 7
Fracture 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Material Twisted/Bent 7 7
Component Misassembled 6 6
Improper or Incorrect Procedure or Method 6 6
Scratched Material 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 641 641
Urinary Tract Infection 190 190
No Consequences Or Impact To Patient 178 178
No Known Impact Or Consequence To Patient 126 126
No Patient Involvement 106 106
Pain 81 81
Hemorrhage/Bleeding 69 69
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 48
Unspecified Tissue Injury 43 43
Unspecified Infection 34 34
Hematuria 34 34
Discomfort 33 33
Sepsis 21 21
Tissue Breakdown 18 18
Burning Sensation 17 17
Blood Loss 17 17
No Code Available 15 15
Foreign Body In Patient 13 13
No Information 13 13
Injury 12 12
Skin Irritation 10 10
Patient Problem/Medical Problem 7 7
Irritation 7 7
Insufficient Information 7 7
Bruise/Contusion 5 5
Genital Bleeding 5 5
Urinary Retention 4 4
Exsanguination 4 4
Perforation 4 4
Itching Sensation 4 4
Exposure to Body Fluids 3 3
Bacterial Infection 3 3
Abrasion 3 3
Skin Inflammation/ Irritation 3 3
Device Embedded In Tissue or Plaque 3 3
Hypersensitivity/Allergic reaction 3 3
Abdominal Pain 3 3
Swelling/ Edema 2 2
Laceration(s) 2 2
Fall 2 2
Skin Tears 2 2
Cancer 2 2
Distress 2 2
Kidney Infection 2 2
Rash 2 2
Fever 2 2
Fungal Infection 2 2
Hematoma 2 2
Local Reaction 2 2
Death 1 1

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 Jun-03-2011
4 Teleflex Medical Europe Ltd II Apr-12-2018
-
-