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 365 365

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 171 171
Device Misassembled During Manufacturing /Shipping 82 82
Break 73 73
Difficult to Open or Remove Packaging Material 65 65
Difficult to Remove 61 61
Sharp Edges 58 58
Delivered as Unsterile Product 54 54
Deflation Problem 46 46
Fluid/Blood Leak 40 40
Biocompatibility 34 34
Patient Device Interaction Problem 34 34
Material Puncture/Hole 31 31
Partial Blockage 28 28
Burst Container or Vessel 28 28
Product Quality Problem 27 27
Material Invagination 26 26
Material Deformation 26 26
Contamination /Decontamination Problem 25 25
Packaging Problem 24 24
Unsealed Device Packaging 21 21
Difficult to Insert 19 19
Leak/Splash 19 19
Decrease in Pressure 19 19
Insufficient Information 17 17
Difficult to Open or Close 16 16
Material Split, Cut or Torn 16 16
Device Damaged Prior to Use 15 15
Device Handling Problem 13 13
Device Markings/Labelling Problem 12 12
Device Contamination with Chemical or Other Material 12 12
Inflation Problem 12 12
Material Too Rigid or Stiff 11 11
Inaccurate Flow Rate 10 10
Material Fragmentation 10 10
Detachment Of Device Component 10 10
Entrapment of Device 9 9
Appropriate Term/Code Not Available 9 9
Detachment of Device or Device Component 8 8
Material Rupture 8 8
Defective Device 8 8
Dent in Material 8 8
Failure to Infuse 8 8
Fracture 7 7
Device Operates Differently Than Expected 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
No Flow 4 4
Use of Device Problem 4 4
Obstruction of Flow 4 4
Patient-Device Incompatibility 4 4
Material Separation 4 4
Inadequacy of Device Shape and/or Size 3 3
Defective Component 3 3
Component Missing 3 3
Split 3 3
Component Falling 3 3
Inadequate Instructions for Healthcare Professional 3 3
Illegible Information 3 3
Physical Resistance/Sticking 3 3
Mushroomed 3 3
Device Contaminated During Manufacture or Shipping 3 3
Activation, Positioning or Separation Problem 3 3
Improper Chemical Reaction 2 2
Improper Flow or Infusion 2 2
Device Dislodged or Dislocated 2 2
Moisture or Humidity Problem 2 2
Material Integrity Problem 2 2
Material Too Soft/Flexible 2 2
Device Fell 2 2
Premature Separation 2 2
Nonstandard Device 2 2
No Device Output 2 2
Hole In Material 2 2
Contamination 2 2
Crack 2 2
Calcified 2 2
Device Inoperable 2 2
Structural Problem 2 2
Physical Resistance 2 2
Off-Label Use 2 2
Device Slipped 2 2
Sticking 2 2
Device Stops Intermittently 1 1
Inadequate or Insufficient Training 1 1
Out-Of-Box Failure 1 1
Device Or Device Fragments Location Unknown 1 1
Ambient Temperature Problem 1 1
Deformation Due to Compressive Stress 1 1
Separation Failure 1 1
Cut In Material 1 1
Complete Blockage 1 1
Restricted Flow rate 1 1
Bent 1 1
Degraded 1 1
Material Discolored 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 626 626
Urinary Tract Infection 187 187
No Consequences Or Impact To Patient 178 178
No Known Impact Or Consequence To Patient 126 126
No Patient Involvement 106 106
Pain 77 77
Hemorrhage/Bleeding 68 68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 46 46
Unspecified Tissue Injury 43 43
Hematuria 34 34
Unspecified Infection 33 33
Discomfort 30 30
Sepsis 21 21
Blood Loss 17 17
Tissue Breakdown 17 17
Burning Sensation 16 16
No Code Available 15 15
No Information 13 13
Injury 12 12
Foreign Body In Patient 12 12
Skin Irritation 10 10
Irritation 7 7
Patient Problem/Medical Problem 7 7
Bruise/Contusion 5 5
Insufficient Information 5 5
Genital Bleeding 5 5
Exsanguination 4 4
Itching Sensation 4 4
Perforation 4 4
Urinary Retention 4 4
Device Embedded In Tissue or Plaque 3 3
Bacterial Infection 3 3
Exposure to Body Fluids 3 3
Abdominal Pain 3 3
Abrasion 3 3
Hypersensitivity/Allergic reaction 2 2
Rash 2 2
Local Reaction 2 2
Laceration(s) 2 2
Fall 2 2
Fever 2 2
Distress 2 2
Skin Tears 2 2
Fungal Infection 2 2
Hematoma 2 2
Cancer 2 2
Kidney Infection 2 2
Swelling/ Edema 2 2
Cramp(s) /Muscle Spasm(s) 1 1
Localized Skin Lesion 1 1
Skin Inflammation/ Irritation 1 1
Drug Resistant Bacterial Infection 1 1
Complaint, Ill-Defined 1 1
Fasciitis 1 1
Reaction 1 1
Coma 1 1
Loss of consciousness 1 1
Uremia 1 1
Chills 1 1
Rupture 1 1
Pressure Sores 1 1
Anxiety 1 1
Tooth Fracture 1 1
Skin Inflammation 1 1
Shaking/Tremors 1 1
Alteration In Body Temperature 1 1
Dysuria 1 1
Fluid Discharge 1 1
Fistula 1 1
Septic Shock 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Tissue Damage 1 1
Internal Organ Perforation 1 1
Renal Failure 1 1
Seizures 1 1
Low Blood Pressure/ Hypotension 1 1
Incontinence 1 1
Fainting 1 1
Abscess 1 1
Anemia 1 1
Cyst(s) 1 1
Death 1 1
Purulent Discharge 1 1
Dyspnea 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
-
-