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TPLC
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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 Code
NZU
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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