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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device needle, suturing, disposable
Product CodeGAB
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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