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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
2021 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 258 258
Appropriate Term/Code Not Available 36 36
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 11 11
Product Quality Problem 6 6
Torn Material 6 6
Detachment of Device or Device Component 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
Obstruction of Flow 3 3
Difficult to Insert 3 3
Fluid Leak 2 2
Component Incompatible 2 2
Contamination 2 2
Microbial Contamination of Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Loss of or Failure to Bond 2 2
Patient-Device Incompatibility 2 2
Expiration Date Error 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Remove Packaging Material 1 1
Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Noise, Audible 1 1
No Apparent Adverse Event 1 1
Improper or Incorrect Procedure or Method 1 1
Peeled/Delaminated 1 1
Complete Blockage 1 1
Detachment Of Device Component 1 1
Migration or Expulsion of Device 1 1
Delivered as Unsterile Product 1 1
Missing Information 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 41 41
Fever 31 31
No Known Impact Or Consequence To Patient 27 27
Hematoma 26 26
Seroma 25 25
Pain 20 20
Inflammation 17 17
Hypersensitivity/Allergic reaction 16 16
Blood Loss 16 16
Hemorrhage/Bleeding 14 14
Asthma 13 13
Hypoxia 13 13
Dyspnea 13 13
Reaction 12 12
Granuloma 11 11
Wound Dehiscence 11 11
Failure to Anastomose 10 10
Death 10 10
No Clinical Signs, Symptoms or Conditions 9 9
Anemia 8 8
Swelling 8 8
Abdominal Pain 8 8
Bacterial Infection 7 7
Paresis 7 7
Sepsis 7 7
Rash 5 5
Erythema 5 5
Purulent Discharge 5 5
Necrosis 5 5
Pleural Effusion 5 5
Obstruction/Occlusion 5 5
Foreign Body In Patient 5 5
Impaired Healing 4 4
Pneumonia 4 4
Paralysis 4 4
Foreign Body Reaction 4 4
Low Blood Pressure/ Hypotension 4 4
Cyst(s) 3 3
Fluid Discharge 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Fistula 3 3
Nerve Damage 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
Adhesion(s) 2 2
Bruise/Contusion 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
Numbness 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
Cellulitis 1 1
Hemostasis 1 1
Itching Sensation 1 1
Nausea 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Weakness 1 1
Infection, Pyrogenic 1 1
Urticaria 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Local Reaction 1 1
Seizures 1 1
Radiation Exposure, Unintended 1 1
Post Operative Wound Infection 1 1
Swelling/ Edema 1 1

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