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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device collector, urine, powered, non indwelling catheter
Definition For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding. Often patient confined to the bed or a wheelchair.
Product CodeNZU
Regulation Number 876.5250
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 25 25
2019 50 50
2020 153 153
2021 605 605
2022 516 516
2023 241 241
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Biocompatibility 438 438
Adverse Event Without Identified Device or Use Problem 423 423
Device Handling Problem 115 115
Increase in Suction 113 113
Inadequate or Insufficient Training 112 112
Patient Device Interaction Problem 112 112
Illegible Information 74 74
Overheating of Device 62 62
Patient-Device Incompatibility 59 59
Fluid/Blood Leak 58 58
Malposition of Device 42 42
Suction Failure 31 31
Missing Information 30 30
Decrease in Suction 30 30
Component Missing 27 27
Positioning Failure 24 24
Suction Problem 23 23
Nonstandard Device 18 18
Labelling, Instructions for Use or Training Problem 11 11
Use of Device Problem 10 10
Sharp Edges 10 10
Misassembly by Users 10 10
Insufficient Information 9 9
Disconnection 7 7
Leak/Splash 7 7
Failure to Power Up 5 5
Appropriate Term/Code Not Available 5 5
No Apparent Adverse Event 5 5
Device Markings/Labelling Problem 5 5
Intermittent Loss of Power 4 4
Component Misassembled 4 4
Inadequate Instructions for Healthcare Professional 4 4
Improper or Incorrect Procedure or Method 4 4
Difficult to Remove 4 4
Fracture 3 3
Incorrect Measurement 3 3
Device Emits Odor 3 3
Therapeutic or Diagnostic Output Failure 3 3
Break 3 3
Device Dislodged or Dislocated 3 3
Device Contamination with Chemical or Other Material 2 2
Detachment of Device or Device Component 2 2
Loss of or Failure to Bond 2 2
Inadequacy of Device Shape and/or Size 2 2
Fitting Problem 2 2
Expiration Date Error 2 2
Incomplete or Missing Packaging 2 2
Fungus in Device Environment 1 1
Obstruction of Flow 1 1
Defective Device 1 1
Microbial Contamination of Device 1 1
Device Slipped 1 1
Stretched 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Separation 1 1
Bent 1 1
Material Fragmentation 1 1
Material Invagination 1 1
Misassembled 1 1
Product Quality Problem 1 1
Loss of Power 1 1
Device Operates Differently Than Expected 1 1
Contamination /Decontamination Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
No Flow 1 1
Unintended Movement 1 1
Positioning Problem 1 1
Scratched Material 1 1
Physical Resistance/Sticking 1 1
Inaccurate Information 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Tract Infection 737 738
No Clinical Signs, Symptoms or Conditions 369 369
Unspecified Infection 168 168
Skin Inflammation/ Irritation 107 107
Rash 71 71
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 61
Pain 51 51
Fungal Infection 48 48
Pressure Sores 36 36
Discomfort 35 35
No Consequences Or Impact To Patient 26 26
Burning Sensation 25 25
Hypersensitivity/Allergic reaction 23 23
No Known Impact Or Consequence To Patient 21 21
Itching Sensation 19 19
Bacterial Infection 19 19
Abrasion 18 18
Tissue Breakdown 18 18
Skin Discoloration 17 17
Blister 16 16
Skin Tears 16 16
Bruise/Contusion 15 15
Sepsis 14 14
Patient Problem/Medical Problem 14 14
Irritation 14 14
No Code Available 13 13
Local Reaction 13 13
Skin Irritation 11 11
Erythema 9 9
Hemorrhage/Bleeding 8 8
Ulcer 8 8
Reaction 8 8
Swelling/ Edema 8 8
No Patient Involvement 7 7
Hematuria 6 6
Injury 5 5
Tissue Damage 5 5
Hematoma 5 5
Abscess 5 5
Insufficient Information 5 5
Laceration(s) 4 4
Localized Skin Lesion 4 4
Electric Shock 3 3
Kidney Infection 3 3
Irritability 3 3
Edema 3 3
Incontinence 3 3
Death 2 2
Skin Erosion 2 2
Unspecified Tissue Injury 2 2
Fecal Incontinence 2 2
Skin Burning Sensation 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Osteomyelitis 1 1
Swelling 1 1
Tachycardia 1 1
Uterine Perforation 1 1
Needle Stick/Puncture 1 1
Loss of consciousness 1 1
Dehydration 1 1
Diarrhea 1 1
Exposure to Body Fluids 1 1
Fall 1 1
Bone Fracture(s) 1 1
Fungus 1 1
Headache 1 1
Wound Dehiscence 1 1
Intimal Dissection 1 1
Abdominal Pain 1 1
Calcium Deposits/Calcification 1 1
Cellulitis 1 1
Cyst(s) 1 1
Inflammation 1 1
Low Blood Pressure/ Hypotension 1 1
Necrosis 1 1
Peeling 1 1
Scar Tissue 1 1
Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sage Products Inc II Nov-21-2023
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