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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device agent, absorbable hemostatic, non-collagen based
Regulation Description Absorbable hemostatic agent and dressing.
Product CodeLMG
Regulation Number 878.4490
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
9 3 6 19 11 2

MDR Year MDR Reports MDR Events
2016 2 2
2017 30 30
2018 84 84
2019 120 120
2020 173 173
2021 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 290 290
Appropriate Term/Code Not Available 37 37
Patient Device Interaction Problem 27 27
Device Markings/Labelling Problem 24 24
Insufficient Information 20 20
Break 15 15
Degraded 13 13
Use of Device Problem 12 12
Product Quality Problem 7 7
Delivered as Unsterile Product 6 6
Detachment of Device or Device Component 6 6
Torn Material 6 6
Unsealed Device Packaging 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Contamination /Decontamination Problem 4 4
Material Integrity Problem 4 4
Difficult to Insert 3 3
Obstruction of Flow 3 3
Patient-Device Incompatibility 2 2
Microbial Contamination of Device 2 2
Fluid Leak 2 2
Loss of or Failure to Bond 2 2
Component Incompatible 2 2
Tear, Rip or Hole in Device Packaging 2 2
Contamination 2 2
Detachment Of Device Component 1 1
Peeled/Delaminated 1 1
Improper or Incorrect Procedure or Method 1 1
Missing Information 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Complete Blockage 1 1
Material Fragmentation 1 1
Migration or Expulsion of Device 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Remove Packaging Material 1 1
Infusion or Flow Problem 1 1
Noise, Audible 1 1
Expiration Date Error 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 118 118
Not Applicable 80 80
No Code Available 51 51
No Consequences Or Impact To Patient 49 49
Abscess 41 41
Fever 33 33
Hematoma 28 28
No Known Impact Or Consequence To Patient 27 27
Seroma 26 26
Pain 21 21
Hemorrhage/Bleeding 18 18
Inflammation 18 18
Wound Dehiscence 17 17
Hypersensitivity/Allergic reaction 16 16
No Clinical Signs, Symptoms or Conditions 16 16
Blood Loss 16 16
Asthma 13 13
Hypoxia 13 13
Dyspnea 13 13
Reaction 12 12
Granuloma 11 11
Death 10 10
Failure to Anastomose 10 10
Abdominal Pain 9 9
Foreign Body In Patient 9 9
Anemia 8 8
Swelling 8 8
Paresis 7 7
Sepsis 7 7
Bacterial Infection 7 7
Nerve Damage 6 6
Fluid Discharge 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Rash 5 5
Erythema 5 5
Obstruction/Occlusion 5 5
Purulent Discharge 5 5
Foreign Body Reaction 5 5
Necrosis 5 5
Pleural Effusion 5 5
Pneumonia 4 4
Paralysis 4 4
Fistula 4 4
Impaired Healing 4 4
Low Blood Pressure/ Hypotension 4 4
Cyst(s) 3 3
Renal Failure 3 3
No Patient Involvement 3 3
Adhesion(s) 3 3
Local Reaction 3 3
Visual Impairment 3 3
Vomiting 2 2
Tachycardia 2 2
Edema 2 2
Bruise/Contusion 2 2
Headache 2 2
Urinary Tract Infection 2 2
No Information 2 2
Injury 2 2
Respiratory Failure 2 2
High Blood Pressure/ Hypertension 2 2
Cerebrospinal Fluid Leakage 2 2
Thrombosis/Thrombus 2 2
Skin Irritation 2 2
Multiple Organ Failure 1 1
Insufficient Information 1 1
Burn(s) 1 1
Pulmonary Embolism 1 1
Air Embolism 1 1
Airway Obstruction 1 1
Exsanguination 1 1
Hematuria 1 1
Hypoesthesia 1 1
Numbness 1 1
Abnormal Vaginal Discharge 1 1
Vaginal Mucosa Damage 1 1
Chills 1 1
Cramp(s) 1 1
Skin Discoloration 1 1
Perforation 1 1
Irritation 1 1
Swelling/ Edema 1 1
Radiation Exposure, Unintended 1 1
Fibrosis 1 1
Meningitis 1 1
Post Operative Wound Infection 1 1
Hemostasis 1 1
Itching Sensation 1 1
Nausea 1 1
Cellulitis 1 1
Tissue Damage 1 1
Seizures 1 1
Weakness 1 1
Infection, Pyrogenic 1 1
Urticaria 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1

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