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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
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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