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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 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 370 370
Off-Label Use 242 242
Improper or Incorrect Procedure or Method 191 191
Lack of Effect 32 32
Defective Device 25 25
Insufficient Information 22 22
Patient-Device Incompatibility 17 17
Device Contamination with Chemical or Other Material 17 19
Use of Device Problem 14 14
Product Quality 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
Delivered as Unsterile Product 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
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 43 43
Hemoptysis 38 38
Partial Hearing Loss 38 38
No Clinical Signs, Symptoms or Conditions 35 35
Hematoma 32 32
Fistula 32 32
Swelling/ Edema 31 31
Low Blood Pressure/ Hypotension 24 24
Death 23 23
Stenosis 23 23
Fever 21 21
Necrosis 21 21
Insufficient Information 21 21
No Code Available 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
Anaphylactic Shock 15 15
Inflammation 14 14
Tachycardia 14 14
Jaundice 14 14
No Known Impact Or Consequence To Patient 14 14
No Patient Involvement 13 15
Wound Dehiscence 13 13
Ischemia 12 12
Vomiting 12 12
No Consequences Or Impact To Patient 11 14
Post Operative Wound Infection 11 11
Laceration(s) 11 11
Perforation 10 10
Paralysis 10 10
Fluid Discharge 10 10
Total Hearing Loss 10 10
Swelling 9 9
Ulcer 9 9
Injury 9 9
Abdominal Pain 9 9
Cyst(s) 8 8
Blood Loss 8 8
Embolism/Embolus 8 8
Unspecified Hepatic or Biliary Problem 8 8
Foreign Body In Patient 7 7
Impaired Healing 7 7
Obstruction/Occlusion 7 7
Urticaria 7 7
Reaction 7 7
Local Reaction 7 7
Embolism 7 7
Adhesion(s) 7 7
Bacterial Infection 7 7
Erythema 6 6
Dysphagia/ Odynophagia 6 6
Liver Damage/Dysfunction 6 6
Nausea 6 6
Thrombosis/Thrombus 6 6
Hydrocephalus 6 6
Liver Failure 6 6
Balance Problems 5 5
Multiple Organ Failure 5 5
Not Applicable 5 5
Discharge 5 5
Pleural Effusion 5 5
Pneumonia 5 5
Headache 5 5
Foreign Body Reaction 5 5
Cardiac Arrest 5 5
Stroke/CVA 4 4
Dyspnea 4 4
Hypoxia 4 4
Discomfort 4 4
Thromboembolism 4 4
Gastrointestinal Hemorrhage 4 4
Cerebral Edema 3 3
Abdominal Distention 3 3
Ascites 3 3
Unspecified Tissue Injury 3 3
Skin Disorders 3 3
Spinal Cord Injury 3 3
Organ Dehiscence 3 3
Dizziness 3 3
Peritonitis 3 3
Numbness 3 3
Renal Failure 3 3
Thrombosis 3 3
Uterine Perforation 3 3
Weakness 3 3
Burning Sensation 3 3
Rupture 3 3
Vertigo 3 3
Pneumothorax 3 3
Nerve Damage 3 3
Neuropathy 3 3
Irritation 3 3

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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