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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 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 441 441
Biocompatibility 439 439
Patient Device Interaction Problem 126 126
Device Handling Problem 117 117
Increase in Suction 116 116
Inadequate or Insufficient Training 112 112
Illegible Information 74 74
Fluid/Blood Leak 63 63
Overheating of Device 62 62
Patient-Device Incompatibility 59 59
Malposition of Device 42 42
Suction Failure 38 38
Decrease in Suction 32 32
Missing Information 30 30
Component Missing 27 27
Positioning Failure 26 26
Suction Problem 23 23
Nonstandard Device 18 18
Labelling, Instructions for Use or Training Problem 11 11
Misassembly by Users 10 10
Sharp Edges 10 10
Use of Device Problem 10 10
Insufficient Information 9 9
Leak/Splash 7 7
Disconnection 7 7
Appropriate Term/Code Not Available 5 5
Component Misassembled 5 5
No Apparent Adverse Event 5 5
Device Markings/Labelling Problem 5 5
Failure to Power Up 5 5
Improper or Incorrect Procedure or Method 4 4
Intermittent Loss of Power 4 4
Difficult to Remove 4 4
Inadequate Instructions for Healthcare Professional 4 4
Therapeutic or Diagnostic Output Failure 3 3
Incorrect Measurement 3 3
Device Emits Odor 3 3
Break 3 3
Device Dislodged or Dislocated 3 3
Fracture 3 3
Fitting Problem 2 2
Expiration Date Error 2 2
Loss of or Failure to Bond 2 2
Incomplete or Missing Packaging 2 2
Device Contamination with Chemical or Other Material 2 2
Inadequacy of Device Shape and/or Size 2 2
Detachment of Device or Device Component 2 2
Wrong Label 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Tract Infection 763 764
No Clinical Signs, Symptoms or Conditions 371 371
Unspecified Infection 172 172
Skin Inflammation/ Irritation 113 113
Rash 75 75
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 63 63
Pain 52 52
Fungal Infection 49 49
Pressure Sores 40 40
Discomfort 36 36
Burning Sensation 28 28
No Consequences Or Impact To Patient 26 26
Hypersensitivity/Allergic reaction 24 24
No Known Impact Or Consequence To Patient 21 21
Tissue Breakdown 20 20
Itching Sensation 20 20
Bacterial Infection 19 19
Abrasion 19 19
Skin Tears 17 17
Skin Discoloration 17 17
Blister 16 16
Bruise/Contusion 15 15
Sepsis 15 15
Patient Problem/Medical Problem 14 14
Irritation 14 14
Local Reaction 14 14
No Code Available 13 13
Skin Irritation 11 11
Erythema 9 9
Hemorrhage/Bleeding 8 8
Reaction 8 8
Swelling/ Edema 8 8
Ulcer 8 8
No Patient Involvement 7 7
Hematuria 6 6
Injury 5 5
Hematoma 5 5
Insufficient Information 5 5
Tissue Damage 5 5
Abscess 5 5
Localized Skin Lesion 4 4
Kidney Infection 4 4
Incontinence 4 4
Laceration(s) 4 4
Edema 3 3
Irritability 3 3
Electric Shock 3 3
Unspecified Tissue Injury 3 3
Skin Erosion 2 2
Fecal Incontinence 2 2

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