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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
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 417 417
Device Handling Problem 115 115
Patient Device Interaction Problem 112 112
Inadequate or Insufficient Training 112 112
Increase in Suction 109 109
Illegible Information 74 74
Overheating of Device 62 62
Fluid/Blood Leak 57 57
Patient-Device Incompatibility 47 47
Malposition of Device 42 42
Suction Failure 31 31
Missing Information 30 30
Decrease in Suction 30 30
Component Missing 25 25
Positioning Failure 24 24
Nonstandard Device 18 18
Suction Problem 18 18
Use of Device Problem 10 10
Sharp Edges 10 10
Misassembly by Users 10 10
Labelling, Instructions for Use or Training Problem 9 9
Insufficient Information 8 8
Leak/Splash 7 7
Failure to Power Up 5 5
Disconnection 5 5
No Apparent Adverse Event 5 5
Device Markings/Labelling Problem 4 4
Intermittent Loss of Power 4 4
Component Misassembled 4 4
Difficult to Remove 4 4
Improper or Incorrect Procedure or Method 3 3
Break 3 3
Inadequate Instructions for Healthcare Professional 3 3
Fracture 3 3
Incorrect Measurement 3 3
Device Emits Odor 3 3
Device Dislodged or Dislocated 3 3
Appropriate Term/Code Not Available 3 3
Therapeutic or Diagnostic Output Failure 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
Incomplete or Missing Packaging 2 2
Expiration Date Error 2 2
Defective Device 1 1
Fungus in Device Environment 1 1
Obstruction of Flow 1 1
Device Slipped 1 1
Stretched 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Separation 1 1
Fitting Problem 1 1
Microbial Contamination of Device 1 1
Material Fragmentation 1 1
Material Invagination 1 1
Misassembled 1 1
Product Quality Problem 1 1
Loss of Power 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
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 733 734
No Clinical Signs, Symptoms or Conditions 369 369
Unspecified Infection 168 168
Skin Inflammation/ Irritation 107 107
Rash 70 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 61
Pain 50 50
Fungal Infection 48 48
Discomfort 35 35
Pressure Sores 34 34
Burning Sensation 25 25
No Consequences Or Impact To Patient 25 25
Hypersensitivity/Allergic reaction 21 21
Bacterial Infection 19 19
Itching Sensation 19 19
Tissue Breakdown 18 18
Abrasion 17 17
Blister 16 16
No Known Impact Or Consequence To Patient 16 16
Skin Tears 14 14
Sepsis 14 14
Skin Discoloration 14 14
Irritation 14 14
Local Reaction 13 13
Bruise/Contusion 12 12
No Code Available 12 12
Patient Problem/Medical Problem 11 11
Erythema 9 9
Swelling/ Edema 8 8
Hemorrhage/Bleeding 6 6
Hematuria 6 6
Skin Irritation 6 6
Ulcer 6 6
Reaction 6 6
No Patient Involvement 5 5
Abscess 5 5
Insufficient Information 5 5
Localized Skin Lesion 4 4
Injury 4 4
Electric Shock 3 3
Irritability 3 3
Kidney Infection 3 3
Unspecified Tissue Injury 2 2
Fecal Incontinence 2 2
Tissue Damage 2 2
Death 2 2
Hematoma 2 2
Incontinence 2 2
Laceration(s) 1 1
Necrosis 1 1
Scar Tissue 1 1
Peeling 1 1
Exposure to Body Fluids 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Dehydration 1 1
Diarrhea 1 1
Edema 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
Loss of consciousness 1 1
Swelling 1 1
Tachycardia 1 1
Uterine Perforation 1 1
Skin Erosion 1 1
Shock 1 1
Skin Burning Sensation 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Osteomyelitis 1 1

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