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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, absorbable, synthetic
Product CodeGAN
Regulation Number 878.4830
Device Class 2

MDR Year MDR Reports MDR Events
2019 434 434
2020 278 278
2021 301 301
2022 328 328
2023 343 343
2024 161 161

Device Problems MDRs with this Device Problem Events in those MDRs
Break 799 799
Material Separation 622 622
Adverse Event Without Identified Device or Use Problem 344 344
Material Integrity Problem 42 42
Tear, Rip or Hole in Device Packaging 36 36
Material Frayed 24 24
Component Misassembled 23 23
Device Markings/Labelling Problem 18 18
Defective Component 16 16
Appropriate Term/Code Not Available 15 15
Positioning Failure 11 11
Product Quality Problem 10 10
Delivered as Unsterile Product 8 8
Degraded 6 6
Dull, Blunt 4 4
Component Missing 3 3
Insufficient Information 3 3
Detachment of Device or Device Component 3 3
Difficult to Open or Remove Packaging Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Component Incompatible 2 2
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Contamination /Decontamination Problem 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 857 857
No Consequences Or Impact To Patient 548 548
Wound Dehiscence 128 128
Unspecified Infection 101 101
Pain 54 54
Not Applicable 47 47
Impaired Healing 46 46
Inflammation 45 45
Post Operative Wound Infection 44 44
Erythema 38 38
Insufficient Information 31 31
Hypersensitivity/Allergic reaction 27 27
Hematoma 26 26
Hemorrhage/Bleeding 25 25
Seroma 25 25
Itching Sensation 22 22
Foreign Body Reaction 22 22
Hernia 20 20
Scar Tissue 18 18
Necrosis 18 18
Foreign Body In Patient 18 18
Abscess 16 16
Purulent Discharge 16 16
No Code Available 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Blood Loss 13 13
Fever 13 13
Fistula 13 13
Rash 13 13
Skin Irritation 12 12
Erosion 12 12
Fluid Discharge 12 12
Swelling 11 11
Local Reaction 9 9
Cellulitis 9 9
Incontinence 8 8
Pocket Erosion 8 8
Skin Inflammation/ Irritation 8 8
Unspecified Tissue Injury 8 8
Urinary Tract Infection 7 7
Swelling/ Edema 6 6
No Known Impact Or Consequence To Patient 6 6
Obstruction/Occlusion 6 6
Failure to Anastomose 5 5
Granuloma 5 5
Urinary Retention 4 4
Ulcer 4 4
Sepsis 4 4
Scarring 3 3
Numbness 3 3
Adhesion(s) 3 3
Abdominal Pain 2 2
Edema 2 2
Bacterial Infection 2 2
Micturition Urgency 2 2
Fall 2 2
Burning Sensation 2 2
Urinary Frequency 2 2
Urticaria 2 2
Discomfort 2 2
Tissue Damage 2 2
Perforation of Vessels 2 2
Nausea 2 2
Hematuria 2 2
Blister 2 2
Chemical Exposure 1 1
Abdominal Distention 1 1
Thromboembolism 1 1
Nervous System Injury 1 1
Fibrosis 1 1
Drug Resistant Bacterial Infection 1 1
Thrombosis/Thrombus 1 1
Renal Impairment 1 1
Muscle/Tendon Damage 1 1
Neuropathy 1 1
Paralysis 1 1
Perforation 1 1
Tachycardia 1 1
Vomiting 1 1
Peritonitis 1 1
Abnormal Vaginal Discharge 1 1
Injury 1 1
Reaction 1 1
Bone Fracture(s) 1 1
Muscular Rigidity 1 1
High Blood Pressure/ Hypertension 1 1
Exposure to Body Fluids 1 1
Cyst(s) 1 1
Diarrhea 1 1
Dysphagia/ Odynophagia 1 1
Ecchymosis 1 1
Adult Respiratory Distress Syndrome 1 1
Bruise/Contusion 1 1
Calcium Deposits/Calcification 1 1
Capsular Contracture 1 1

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