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TPLC
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show TPLC since
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Device
needle, suturing, disposable
Product Code
GAB
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2017
44
44
2018
59
59
2019
30
30
2020
26
26
2021
17
139
2022
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
91
91
Material Fragmentation
20
20
Fracture
17
17
Adverse Event Without Identified Device or Use Problem
9
9
Patient-Device Incompatibility
7
7
Material Protrusion/Extrusion
7
7
Insufficient Information
7
7
Device Operates Differently Than Expected
5
5
Detachment Of Device Component
5
5
Detachment of Device or Device Component
4
4
Material Integrity Problem
3
3
Device Or Device Fragments Location Unknown
3
3
Material Separation
3
3
Material Puncture/Hole
2
2
Improper or Incorrect Procedure or Method
2
2
Component Missing
2
2
Entrapment of Device
2
2
Unintended Ejection
2
2
Delivered as Unsterile Product
2
2
Appropriate Term/Code Not Available
2
2
Material Twisted/Bent
2
2
Device Fell
1
1
Positioning Problem
1
1
Therapeutic or Diagnostic Output Failure
1
123
Unintended Movement
1
1
Peeled/Delaminated
1
1
Bent
1
1
Device Contamination with Body Fluid
1
1
Tear, Rip or Hole in Device Packaging
1
1
Product Quality Problem
1
1
Device Slipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
54
54
Foreign Body In Patient
30
30
Device Embedded In Tissue or Plaque
19
19
Wound Dehiscence
18
18
No Clinical Signs, Symptoms or Conditions
15
15
Skin Irritation
10
10
No Consequences Or Impact To Patient
7
7
No Information
7
7
Unspecified Infection
6
6
Foreign Body Reaction
5
5
Pain
5
5
No Code Available
4
4
Needle Stick/Puncture
4
4
Discharge
3
3
Swelling
2
2
Tissue Damage
2
2
Failure to Anastomose
2
2
Erythema
2
2
No Patient Involvement
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
124
Fluid Discharge
1
1
Organ Dehiscence
1
1
Patient Problem/Medical Problem
1
1
Bone Fracture(s)
1
1
High Blood Pressure/ Hypertension
1
1
Abscess
1
1
Bacterial Infection
1
1
Bruise/Contusion
1
1
Cyst(s)
1
1
Purulent Discharge
1
1
Necrosis
1
1
Injury
1
1
Reaction
1
1
Numbness
1
1
Obstruction/Occlusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medline Industries Inc
II
May-25-2018
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