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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, collagen based
Product CodeLMF
Regulation Number 878.4490
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
23 15 27 16 20 5

MDR Year MDR Reports MDR Events
2019 150 155
2020 146 146
2021 96 96
2022 58 58
2023 271 271
2024 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 366 366
Off-Label Use 240 240
Improper or Incorrect Procedure or Method 190 190
Lack of Effect 31 31
Defective Device 25 25
Insufficient Information 22 22
Patient-Device Incompatibility 17 17
Device Contamination with Chemical or Other Material 17 19
Product Quality Problem 12 12
Use of Device Problem 12 12
Therapeutic or Diagnostic Output Failure 11 11
Fail-Safe Did Not Operate 9 9
Appropriate Term/Code Not Available 6 6
False Positive Result 6 6
Break 5 5
Insufficient Heating 4 4
Unexpected Therapeutic Results 3 3
Migration or Expulsion of Device 3 3
Particulates 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Inadequate Instructions for Healthcare Professional 2 2
Material Twisted/Bent 2 2
Compatibility Problem 2 2
Device Markings/Labelling Problem 2 2
Defective Component 2 2
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Obstruction of Flow 1 1
Difficult or Delayed Activation 1 1
Failure to Cut 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Contamination /Decontamination Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
No Pressure 1 4
Output Problem 1 1
Mechanical Problem 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Complete Blockage 1 1
Clumping in Device or Device Ingredient 1 1
Component Incompatible 1 1
Decrease in Suction 1 1
Loss of or Failure to Bond 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 93 93
Unspecified Infection 53 53
Abscess 47 47
Pain 42 42
Hemoptysis 38 38
Partial Hearing Loss 38 38
No Clinical Signs, Symptoms or Conditions 32 32
Fistula 32 32
Hematoma 31 31
Swelling/ Edema 31 31
Low Blood Pressure/ Hypotension 24 24
Death 23 23
Stenosis 23 23
Fever 21 21
Insufficient Information 21 21
No Code Available 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Necrosis 20 20
Hypersensitivity/Allergic reaction 19 19
Cerebrospinal Fluid Leakage 19 19
Hearing Impairment 18 18
Sepsis 16 16
Pseudoaneurysm 16 16
Meningitis 15 15
Tachycardia 14 14
Jaundice 14 14
Inflammation 14 14
Anaphylactic Shock 14 14
No Known Impact Or Consequence To Patient 14 14
No Patient Involvement 13 15
Vomiting 12 12
Wound Dehiscence 12 12
Ischemia 12 12
Laceration(s) 11 11
No Consequences Or Impact To Patient 11 14
Paralysis 10 10
Post Operative Wound Infection 10 10
Perforation 10 10
Total Hearing Loss 10 10
Fluid Discharge 9 9
Abdominal Pain 9 9
Ulcer 9 9
Injury 9 9
Swelling 9 9
Blood Loss 8 8
Cyst(s) 8 8
Unspecified Hepatic or Biliary Problem 8 8
Embolism/Embolus 7 7
Foreign Body In Patient 7 7
Embolism 7 7
Adhesion(s) 7 7
Bacterial Infection 7 7
Urticaria 7 7
Reaction 7 7
Obstruction/Occlusion 7 7
Local Reaction 7 7
Nausea 6 6
Impaired Healing 6 6
Erythema 6 6
Dysphagia/ Odynophagia 6 6
Liver Damage/Dysfunction 6 6
Hydrocephalus 6 6
Thrombosis/Thrombus 6 6
Liver Failure 6 6
Multiple Organ Failure 5 5
Balance Problems 5 5
Not Applicable 5 5
Pleural Effusion 5 5
Pneumonia 5 5
Headache 5 5
Foreign Body Reaction 5 5
Discharge 5 5
Discomfort 4 4
Cardiac Arrest 4 4
Stroke/CVA 4 4
Hypoxia 4 4
Gastrointestinal Hemorrhage 4 4
Ascites 3 3
Cerebral Edema 3 3
Skin Disorders 3 3
Unspecified Tissue Injury 3 3
Pneumothorax 3 3
Nerve Damage 3 3
Neuropathy 3 3
Irritation 3 3
Muscle Weakness 3 3
Dyspnea 3 3
Spinal Cord Injury 3 3
Numbness 3 3
Dizziness 3 3
Peritonitis 3 3
Abdominal Distention 3 3
Thromboembolism 3 3
Rupture 3 3
Weakness 3 3
Vertigo 3 3
Renal Failure 3 3
Thrombosis 3 3
Thrombus 2 2
Scar Tissue 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-05-2024
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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