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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)
2018 2019 2020 2021 2022 2023
16 23 15 27 16 20

MDR Year MDR Reports MDR Events
2018 108 112
2019 150 155
2020 146 146
2021 96 96
2022 58 58
2023 258 258

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 367 367
Off-Label Use 227 227
Improper or Incorrect Procedure or Method 176 176
Device Contamination with Chemical or Other Material 33 39
Insufficient Information 27 27
Lack of Effect 27 27
Defective Device 26 26
Patient-Device Incompatibility 25 25
Appropriate Term/Code Not Available 23 23
Use of Device Problem 12 12
Product Quality Problem 12 12
Therapeutic or Diagnostic Output Failure 11 11
Fail-Safe Did Not Operate 9 9
Device Markings/Labelling Problem 6 6
Migration or Expulsion of Device 6 6
Break 6 6
False Positive Result 6 6
Unexpected Therapeutic Results 5 5
Insufficient Heating 4 4
Device Operates Differently Than Expected 4 4
Device Dislodged or Dislocated 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Inadequate Instructions for Healthcare Professional 2 2
Component Incompatible 2 2
Particulates 2 2
Defective Component 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Difficult to Open or Remove Packaging Material 1 1
Torn Material 1 1
No Pressure 1 4
Output Problem 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Explosion 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Device Contamination with Body Fluid 1 1
Obstruction of Flow 1 1
Failure to Cut 1 1
Loss of or Failure to Bond 1 1
Contamination /Decontamination Problem 1 1
Activation, Positioning or Separation Problem 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Decrease in Suction 1 1
Entrapment of Device 1 1
Complete Blockage 1 1
Clumping in Device or Device Ingredient 1 1
Mechanical Problem 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Material Too Rigid or Stiff 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Occlusion Within Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 98 98
Unspecified Infection 54 54
Abscess 50 50
Pain 42 42
Hematoma 39 39
Partial Hearing Loss 38 38
No Code Available 37 37
Hemoptysis 37 37
Fistula 34 34
Swelling/ Edema 29 29
No Patient Involvement 28 34
No Clinical Signs, Symptoms or Conditions 27 27
Death 26 26
Low Blood Pressure/ Hypotension 23 23
No Consequences Or Impact To Patient 23 26
Stenosis 21 21
Fever 21 21
Cerebrospinal Fluid Leakage 21 21
Necrosis 20 20
Insufficient Information 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Inflammation 19 19
Hypersensitivity/Allergic reaction 19 19
Hearing Impairment 18 18
Not Applicable 18 18
No Known Impact Or Consequence To Patient 17 17
Pseudoaneurysm 17 17
Meningitis 17 17
Sepsis 16 16
Vomiting 16 16
Jaundice 14 14
Swelling 14 14
Tachycardia 14 14
Anaphylactic Shock 14 14
Blood Loss 14 14
Ischemia 12 12
Post Operative Wound Infection 12 12
Paralysis 11 11
Laceration(s) 11 11
Foreign Body Reaction 10 10
Abdominal Pain 10 10
Perforation 10 10
Injury 10 10
Total Hearing Loss 10 10
Ulcer 9 9
Cyst(s) 8 8
Unspecified Hepatic or Biliary Problem 8 8
Fluid Discharge 8 8
Foreign Body In Patient 7 7
Hydrocephalus 7 7
Embolism/Embolus 7 7
Embolism 7 7
Headache 7 7
Nausea 7 7
Urticaria 7 7
Obstruction/Occlusion 7 7
Reaction 7 7
Local Reaction 7 7
Liver Damage/Dysfunction 6 6
Erythema 6 6
Dysphagia/ Odynophagia 6 6
Adhesion(s) 6 6
Thrombosis/Thrombus 6 6
Liver Failure 6 6
Balance Problems 5 5
Multiple Organ Failure 5 5
Wound Dehiscence 5 5
Dyspnea 5 5
Stroke/CVA 5 5
Hypoxia 5 5
Pleural Effusion 5 5
Pneumonia 5 5
Discharge 5 5
Discomfort 4 4
Peritonitis 4 4
Impaired Healing 4 4
Weakness 4 4
Irritation 4 4
Pulmonary Embolism 4 4
Cardiac Arrest 4 4
Gastrointestinal Hemorrhage 4 4
Ascites 3 3
Skin Disorders 3 3
Unspecified Tissue Injury 3 3
Abdominal Distention 3 3
Thromboembolism 3 3
Bacterial Infection 3 3
Nerve Damage 3 3
Neuropathy 3 3
Vertigo 3 3
Dizziness 3 3
Renal Failure 3 3
Pneumothorax 3 3
Thrombosis 3 3
Thrombus 3 3
Respiratory Failure 3 3
Numbness 3 3
Spinal Cord Injury 3 3
Hernia 3 3
Rupture 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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