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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 0

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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 235 235
Appropriate Term/Code Not Available 34 34
Patient Device Interaction Problem 27 27
Device Markings/Labelling Problem 21 21
Insufficient Information 20 20
Break 15 15
Degraded 13 13
Use of Device Problem 11 11
Detachment of Device or Device Component 6 6
Torn Material 6 6
Product Quality Problem 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
Microbial Contamination of Device 2 2
Fluid Leak 2 2
Loss of or Failure to Bond 2 2
Component Incompatible 2 2
Patient-Device Incompatibility 2 2
Contamination 2 2
Tear, Rip or Hole in Device Packaging 2 2
Improper or Incorrect Procedure or Method 1 1
Detachment Of Device Component 1 1
Peeled/Delaminated 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Missing Information 1 1
No Apparent Adverse Event 1 1
Noise, Audible 1 1
Complete Blockage 1 1
Migration or Expulsion of Device 1 1
Expiration Date Error 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Remove Packaging Material 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 113 113
Not Applicable 80 80
No Code Available 51 51
No Consequences Or Impact To Patient 49 49
Abscess 40 40
Fever 31 31
No Known Impact Or Consequence To Patient 27 27
Hematoma 26 26
Seroma 24 24
Pain 19 19
Inflammation 17 17
Blood Loss 16 16
Hemorrhage/Bleeding 13 13
Reaction 12 12
Granuloma 11 11
Wound Dehiscence 11 11
Death 10 10
Failure to Anastomose 9 9
Anemia 8 8
Swelling 8 8
Abdominal Pain 8 8
Bacterial Infection 7 7
Paresis 7 7
Rash 5 5
Erythema 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Purulent Discharge 5 5
Necrosis 5 5
Obstruction/Occlusion 5 5
Pleural Effusion 5 5
Foreign Body In Patient 5 5
Pneumonia 4 4
Paralysis 4 4
Foreign Body Reaction 4 4
Low Blood Pressure/ Hypotension 4 4
Hypersensitivity/Allergic reaction 4 4
Cyst(s) 3 3
Sepsis 3 3
Fluid Discharge 3 3
Fistula 3 3
Nerve Damage 3 3
Impaired Healing 3 3
Visual Impairment 3 3
No Patient Involvement 3 3
No Information 2 2
Vomiting 2 2
Injury 2 2
Headache 2 2
Edema 2 2
Bruise/Contusion 2 2
Adhesion(s) 2 2
Skin Irritation 2 2
Cerebrospinal Fluid Leakage 2 2
Burn(s) 1 1
Pulmonary Embolism 1 1
Air Embolism 1 1
Airway Obstruction 1 1
Exsanguination 1 1
High Blood Pressure/ Hypertension 1 1
Skin Discoloration 1 1
Hypoesthesia 1 1
Respiratory Failure 1 1
Hematuria 1 1
Renal Failure 1 1
Irritation 1 1
Abnormal Vaginal Discharge 1 1
Vaginal Mucosa Damage 1 1
Chills 1 1
Cramp(s) 1 1
Multiple Organ Failure 1 1
Asthma 1 1
Cellulitis 1 1
Hemostasis 1 1
Itching Sensation 1 1
Nausea 1 1
Post Operative Wound Infection 1 1
Weakness 1 1
Infection, Pyrogenic 1 1
Urticaria 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Local Reaction 1 1
Seizures 1 1
Swelling/ Edema 1 1
Radiation Exposure, Unintended 1 1

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