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TPLC
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Device
catheter, urological
Product Code
KOD
Regulation Number
876.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALLWIN MEDICAL DEVICES, INC
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
4
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
UROGEN PHARMA LTD
SUBSTANTIALLY EQUIVALENT
1
UROGEN PHARMA LTD.
SUBSTANTIALLY EQUIVALENT
1
WELL LEAD MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1180
1180
2019
1167
1167
2020
1370
1370
2021
1387
1387
2022
1280
1280
2023
772
772
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
850
850
Material Twisted/Bent
484
484
Adverse Event Without Identified Device or Use Problem
468
468
Difficult to Remove
448
448
Difficult to Insert
447
447
Product Quality Problem
427
427
Improper Chemical Reaction
367
367
Deflation Problem
359
359
Short Fill
312
312
Incorrect Measurement
306
306
Nonstandard Device
297
297
Component Missing
282
282
Material Integrity Problem
230
230
Fluid/Blood Leak
219
219
Component Misassembled
219
219
Decrease in Pressure
218
218
Misassembled
208
208
Device Damaged Prior to Use
194
194
Patient-Device Incompatibility
139
139
Break
138
138
Partial Blockage
132
132
Material Rupture
132
132
Biocompatibility
122
122
Sharp Edges
121
121
Material Puncture/Hole
110
110
Contamination /Decontamination Problem
109
109
Failure to Infuse
106
106
Material Deformation
101
101
Inadequacy of Device Shape and/or Size
96
96
Inaccurate Flow Rate
94
94
Material Fragmentation
89
89
Leak/Splash
86
86
Material Split, Cut or Torn
82
82
Scratched Material
74
74
Material Too Rigid or Stiff
68
68
Defective Device
62
62
Patient Device Interaction Problem
59
59
No Flow
54
54
Device Slipped
52
52
Device Contamination with Chemical or Other Material
49
49
Device Fell
47
47
Packaging Problem
46
46
Material Protrusion/Extrusion
46
46
Tear, Rip or Hole in Device Packaging
46
46
Difficult to Open or Remove Packaging Material
45
45
Inflation Problem
45
45
Device Handling Problem
45
45
Device Operates Differently Than Expected
43
43
Inability to Irrigate
42
42
Manufacturing, Packaging or Shipping Problem
41
41
Detachment of Device or Device Component
40
40
Use of Device Problem
40
40
Obstruction of Flow
39
39
Deformation Due to Compressive Stress
38
38
Defective Component
37
37
Appropriate Term/Code Not Available
36
36
Therapeutic or Diagnostic Output Failure
36
36
Physical Resistance/Sticking
32
32
Bent
29
29
Failure to Align
28
28
Material Separation
27
27
Device Contaminated During Manufacture or Shipping
26
26
Device Dislodged or Dislocated
25
25
Fracture
24
24
Device Misassembled During Manufacturing /Shipping
22
22
Naturally Worn
22
22
Illegible Information
21
21
Device Markings/Labelling Problem
21
21
Inadequate Instructions for Healthcare Professional
20
20
Moisture or Humidity Problem
20
20
Insufficient Information
20
20
Material Too Soft/Flexible
19
19
Failure to Deflate
19
19
Peeled/Delaminated
19
19
Incomplete or Missing Packaging
18
18
Positioning Problem
18
18
Disconnection
17
17
Restricted Flow rate
16
16
Improper or Incorrect Procedure or Method
16
16
Structural Problem
15
15
Calcified
15
15
Unintended Deflation
15
15
Missing Information
14
14
Malposition of Device
14
14
Shipping Damage or Problem
13
13
Infusion or Flow Problem
13
13
Filling Problem
13
13
Gel Leak
13
13
Complete Blockage
12
12
Contamination
12
12
Crack
11
11
Material Invagination
11
11
Failure to Advance
9
9
Dent in Material
9
9
Fitting Problem
8
8
Mechanical Problem
8
8
Unsealed Device Packaging
8
8
Off-Label Use
8
8
Entrapment of Device
8
8
Physical Property Issue
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2732
2732
No Consequences Or Impact To Patient
1994
1994
No Known Impact Or Consequence To Patient
1718
1718
Urinary Tract Infection
542
542
No Patient Involvement
536
536
Pain
490
490
Patient Problem/Medical Problem
355
355
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
334
334
Hemorrhage/Bleeding
243
243
Discomfort
204
204
Blood Loss
92
92
Hematuria
91
91
No Code Available
66
66
Foreign Body In Patient
65
65
Unspecified Infection
62
62
No Information
60
61
Bacterial Infection
53
53
Insufficient Information
49
49
Irritation
37
37
Urinary Retention
36
36
Abrasion
20
20
Skin Inflammation/ Irritation
19
19
Tissue Damage
17
17
Sepsis
17
17
Tissue Breakdown
15
15
Abdominal Distention
14
14
Injury
14
14
Perforation
12
12
Abdominal Pain
12
12
Bruise/Contusion
11
11
Incontinence
11
11
Obstruction/Occlusion
11
11
Irritability
10
10
Device Embedded In Tissue or Plaque
10
10
Fistula
10
10
Skin Irritation
9
9
Swelling
9
9
Renal Failure
9
9
Burning Sensation
8
8
Laceration(s)
7
7
Cancer
7
7
Anxiety
7
7
Unspecified Gastrointestinal Problem
6
6
Urinary Incontinence
6
6
Swelling/ Edema
6
6
Septic Shock
6
6
Skin Discoloration
6
6
High Blood Pressure/ Hypertension
6
6
Inflammation
5
5
Fever
5
5
Skin Tears
5
5
Dysuria
4
4
Unspecified Tissue Injury
4
4
Itching Sensation
4
4
Internal Organ Perforation
4
4
Hypersensitivity/Allergic reaction
3
3
Death
3
3
Abscess
3
3
Chest Pain
2
2
Erythema
2
2
Headache
2
2
Chills
2
2
Vomiting
2
2
Rupture
2
2
Urinary Frequency
2
2
Pressure Sores
2
2
Scar Tissue
2
2
Pneumothorax
2
2
Rash
2
2
Local Reaction
2
2
Muscle Spasm(s)
2
2
Genital Bleeding
2
2
Cramp(s) /Muscle Spasm(s)
2
2
Test Result
2
2
Pseudoaneurysm
2
2
Respiratory Failure
2
2
Distress
2
2
Fungal Infection
2
2
Post Operative Wound Infection
2
2
Diaphoresis
1
1
Prolapse
1
1
Skin Inflammation
1
1
Sweating
1
1
Confusion/ Disorientation
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Respiratory Insufficiency
1
1
Kidney Infection
1
1
Muscle Weakness
1
1
Nausea
1
1
Liver Damage/Dysfunction
1
1
Pleural Effusion
1
1
Pneumonia
1
1
Scarring
1
1
Therapeutic Effects, Unexpected
1
1
Joint Swelling
1
1
Malaise
1
1
Inadequate Pain Relief
1
1
Laceration(s) of Esophagus
1
1
Extubate
1
1
Mediastinal Shift
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
C.R. Bard Inc
II
Feb-24-2022
2
C.R. Bard, Inc.
II
Apr-16-2021
3
COVIDIEN LLC
II
Sep-20-2018
4
ConvaTec, Inc
II
Mar-21-2019
5
Covidien Llc
II
May-14-2020
6
TELEFLEX LLC
II
Nov-11-2022
7
Teleflex Medical
II
Jul-26-2019
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