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TPLC
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show TPLC since
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Device
stent, ureteral
Product Code
FAD
Regulation Number
876.4620
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALLWIN MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
BOSTON SCIENTIFIC CORP.
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
3
SUBSTANTIALLY EQUIVALENT - KIT
3
BRIGHTWATER MEDICAL
SUBSTANTIALLY EQUIVALENT
1
COLOPLAST CORP
SUBSTANTIALLY EQUIVALENT - KIT
2
SUBSTANTIALLY EQUIVALENT
5
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT - KIT
4
SUBSTANTIALLY EQUIVALENT
9
DORNIER MEDTECH AMERICA INC.
SUBSTANTIALLY EQUIVALENT
1
PROMEPLA SAM
SUBSTANTIALLY EQUIVALENT
1
Q UROLOGICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
3
ROCAMED SAM
SUBSTANTIALLY EQUIVALENT
1
URETERAL STENT COMPANY
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
78
78
2015
130
130
2016
182
182
2017
265
265
2018
277
277
2019
261
261
2020
352
352
2021
531
531
2022
559
559
2023
691
691
2024
212
212
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
789
789
Material Fragmentation
405
405
Calcified
317
317
Adverse Event Without Identified Device or Use Problem
253
253
Difficult to Remove
248
248
Material Separation
161
161
Material Split, Cut or Torn
158
158
Material Deformation
140
140
Migration
130
130
Detachment of Device or Device Component
109
109
Difficult to Advance
106
106
Patient Device Interaction Problem
98
98
Biocompatibility
98
98
Deformation Due to Compressive Stress
94
94
Fracture
77
77
Device Damaged Prior to Use
64
64
Wrong Label
47
47
Migration or Expulsion of Device
41
41
Device Dislodged or Dislocated
39
39
Obstruction of Flow
37
37
Knotted
37
37
Material Twisted/Bent
36
36
Component Missing
35
35
Partial Blockage
35
35
Crack
33
33
Torn Material
33
33
Detachment Of Device Component
32
32
Kinked
30
30
Use of Device Problem
30
30
Difficult to Insert
29
29
Tear, Rip or Hole in Device Packaging
28
28
Unsealed Device Packaging
27
27
Material Integrity Problem
24
24
Device Contamination with Chemical or Other Material
23
23
Entrapment of Device
23
23
Off-Label Use
21
21
Appropriate Term/Code Not Available
21
21
Split
20
20
Device Operates Differently Than Expected
20
20
Improper or Incorrect Procedure or Method
19
19
Accessory Incompatible
19
19
Complete Blockage
18
18
Inadequate Instructions for Healthcare Professional
18
18
Out-Of-Box Failure
18
18
Occlusion Within Device
17
17
Device Contaminated During Manufacture or Shipping
16
16
Packaging Problem
15
15
Material Too Rigid or Stiff
15
15
Insufficient Information
14
14
Component Misassembled
13
13
Failure to Advance
13
13
Incorrect Measurement
13
13
Nonstandard Device
12
12
Unraveled Material
12
12
Stretched
11
11
Flaked
11
11
Bent
11
11
Defective Device
11
11
Device Handling Problem
11
11
Positioning Problem
11
11
Inaccurate Flow Rate
10
10
Disconnection
9
9
Peeled/Delaminated
9
9
Activation, Positioning or Separation Problem
9
9
Device Packaging Compromised
9
9
Device-Device Incompatibility
9
9
Device Markings/Labelling Problem
9
9
Patient-Device Incompatibility
8
8
Defective Component
8
8
Material Rupture
7
7
Material Frayed
7
7
Expiration Date Error
7
7
Physical Resistance/Sticking
7
7
No Flow
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Fluid/Blood Leak
6
6
Positioning Failure
6
6
Material Disintegration
5
5
Delivered as Unsterile Product
5
5
Activation Failure
5
5
Dent in Material
4
4
Malfunction
4
4
Device Misassembled During Manufacturing /Shipping
4
4
Contamination /Decontamination Problem
4
4
Contamination
4
4
Component(s), broken
4
4
Device Fell
4
4
Missing Information
3
3
Material Erosion
3
3
Leak/Splash
3
3
Material Puncture/Hole
3
3
Product Quality Problem
3
3
Inadequacy of Device Shape and/or Size
3
3
Device Operational Issue
3
3
Device Damaged by Another Device
3
3
Separation Failure
3
3
Incomplete or Missing Packaging
3
3
Structural Problem
3
3
Material Too Soft/Flexible
3
3
No Apparent Adverse Event
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1529
1529
No Consequences Or Impact To Patient
656
656
No Known Impact Or Consequence To Patient
464
464
No Patient Involvement
190
190
Pain
174
174
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
150
150
No Code Available
131
131
Foreign Body In Patient
98
98
Insufficient Information
69
69
Hematuria
59
59
Unspecified Infection
59
59
Urinary Tract Infection
57
57
Discomfort
53
53
No Information
42
42
Obstruction/Occlusion
36
36
Device Embedded In Tissue or Plaque
33
33
Unspecified Kidney or Urinary Problem
30
30
Calcium Deposits/Calcification
25
25
Urinary Retention
24
24
Hemorrhage/Bleeding
23
23
Micturition Urgency
21
21
Dysuria
20
20
Swelling/ Edema
19
19
Fever
17
17
Abdominal Pain
14
14
Sepsis
14
14
Patient Problem/Medical Problem
14
14
Surgical procedure, additional
13
13
Fistula
13
13
Failure of Implant
11
11
Foreign body, removal of
11
11
Urinary Frequency
11
11
Post Operative Wound Infection
11
11
Perforation
10
10
Inflammation
9
9
Occlusion
9
9
Renal Failure
9
9
Swelling
8
8
Injury
7
7
Internal Organ Perforation
6
6
Incontinence
6
6
Erosion
5
5
Death
5
5
Bacterial Infection
5
5
Exposure to Body Fluids
3
3
Foreign Body Reaction
3
3
Edema
3
3
Hematoma
3
3
Hypersensitivity/Allergic reaction
3
3
Irritation
3
3
Tachycardia
3
3
Nausea
3
3
Other (for use when an appropriate patient code cannot be identified)
3
3
Irritability
3
3
Urethral Stenosis/Stricture
3
3
Skin Inflammation/ Irritation
3
3
Urinary Incontinence
3
3
Kidney Infection
2
2
Stenosis
2
2
Reaction
2
2
Vomiting
2
2
Chills
2
2
Skin Discoloration
2
2
Laceration(s)
2
2
Extravasation
2
2
Dyspnea
2
2
Vessel Or Plaque, Device Embedded In
2
2
Bleeding
1
1
Abrasion
1
1
Abscess
1
1
Adhesion(s)
1
1
Anemia
1
1
Awareness during Anaesthesia
1
1
Chest Pain
1
1
Liver Damage/Dysfunction
1
1
Pleural Effusion
1
1
Local Reaction
1
1
Low Blood Pressure/ Hypotension
1
1
Headache
1
1
Skin Erosion
1
1
Septic Shock
1
1
Shock
1
1
Surgical procedure, repeated
1
1
Respiratory Distress
1
1
Concussion
1
1
Burning Sensation
1
1
Fungal Infection
1
1
Skin Inflammation
1
1
Impaired Healing
1
1
Sore Throat
1
1
Unknown (for use when the patient's condition is not known)
1
1
Infection, Pyrogenic
1
1
Migration
1
1
Peritonitis
1
1
Nonresorbable materials, unretrieved in body
1
1
Urticaria
1
1
Blockage
1
1
Vesicovaginal Fistula
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Skin Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Dec-30-2020
2
Boston Scientific Corporation
II
May-21-2009
3
C.R. Bard, Inc.
II
Nov-14-2016
4
Cook Inc.
II
Feb-05-2021
5
Cook Inc.
II
Sep-15-2020
6
Cook Inc.
II
Feb-04-2020
7
Hobbs Medical, Inc.
II
Oct-07-2022
8
Vance Products Incorporated
II
Jun-25-2015
9
Vance Products Incorporated
II
Jan-05-2011
10
Vance Products Incorporated
II
Feb-10-2009
11
Vance Products Incorporated
II
Jan-23-2009
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