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TPLC
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Device
catheter, ureteral, gastro-urology
Product Code
EYB
Regulation Number
876.5130
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT - KIT
2
DORNIER MEDTECH AMERICA INC
SUBSTANTIALLY EQUIVALENT
1
PROMEPAL SAM
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
22
22
2020
13
13
2021
11
11
2022
5
5
2023
23
23
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
19
19
Material Puncture/Hole
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Incorrect Measurement
6
6
Inflation Problem
5
5
Device Contaminated During Manufacture or Shipping
5
5
Material Twisted/Bent
4
4
Deflation Problem
4
4
Material Fragmentation
4
4
Inaccurate Flow Rate
3
3
Device Markings/Labelling Problem
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Patient Device Interaction Problem
2
2
Break
2
2
Material Separation
2
2
Leak/Splash
2
2
Nonstandard Device
2
2
Defective Component
2
2
Obstruction of Flow
1
1
Defective Device
1
1
Patient-Device Incompatibility
1
1
Deformation Due to Compressive Stress
1
1
Contamination /Decontamination Problem
1
1
Fitting Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Misassembled
1
1
Material Split, Cut or Torn
1
1
Device Fell
1
1
Wrong Label
1
1
Material Deformation
1
1
Difficult to Advance
1
1
No Flow
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
34
34
No Consequences Or Impact To Patient
21
21
No Known Impact Or Consequence To Patient
14
14
No Patient Involvement
2
2
Foreign Body In Patient
2
2
Laceration(s)
2
2
Pain
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Rash
1
1
Fever
1
1
Unspecified Infection
1
1
Discomfort
1
1
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
No Code Available
1
1
Renal Impairment
1
1
Kidney Infection
1
1
Blister
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hobbs Medical, Inc.
II
Oct-07-2022
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