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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 8

MDR Year MDR Reports MDR Events
2019 150 155
2020 146 146
2021 96 96
2022 58 58
2023 271 271
2024 78 78

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 374 374
Off-Label Use 243 243
Improper or Incorrect Procedure or Method 192 192
Lack of Effect 37 37
Defective Device 25 25
Insufficient Information 22 22
Appropriate Term/Code Not Available 22 22
Patient-Device Incompatibility 19 19
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
False Positive Result 6 6
Break 5 5
Insufficient Heating 4 4
Migration or Expulsion of Device 3 3
Delivered as Unsterile Product 3 3
Unexpected Therapeutic Results 3 3
Defective Component 2 2
Device Markings/Labelling Problem 2 2
Compatibility Problem 2 2
Particulates 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Inadequate Instructions for Healthcare Professional 2 2
Clumping in Device or Device Ingredient 2 2
Material Twisted/Bent 2 2
No Pressure 1 4
Output Problem 1 1
Patient Device Interaction Problem 1 1
Explosion 1 1
Component Incompatible 1 1
Cross Reactivity 1 1
Decrease in Suction 1 1
Complete Blockage 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Mechanical Problem 1 1
Misconnection 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Inadequate User Interface 1 1
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
Loss of or Failure to Bond 1 1
Contamination /Decontamination Problem 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 44 44
Hemoptysis 38 38
Partial Hearing Loss 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
No Clinical Signs, Symptoms or Conditions 36 36
Hematoma 32 32
Fistula 32 32
Swelling/ Edema 31 31
Low Blood Pressure/ Hypotension 24 24
Necrosis 24 24
Death 23 23
Stenosis 23 23
Fever 21 21
Insufficient Information 21 21
No Code Available 21 21
Hypersensitivity/Allergic reaction 20 20
Cerebrospinal Fluid Leakage 19 19
Hearing Impairment 18 18
Wound Dehiscence 16 16
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
Vomiting 12 12
Ischemia 12 12
Laceration(s) 11 11
No Consequences Or Impact To Patient 11 14
Post Operative Wound Infection 11 11
Paralysis 10 10
Perforation 10 10
Fluid Discharge 10 10
Total Hearing Loss 10 10
Liver Failure 9 9
Unspecified Hepatic or Biliary Problem 9 9
Abdominal Pain 9 9
Swelling 9 9
Ulcer 9 9
Injury 9 9
Impaired Healing 8 8
Blood Loss 8 8
Cyst(s) 8 8
Embolism/Embolus 8 8
Foreign Body In Patient 7 7
Embolism 7 7
Erythema 7 7
Adhesion(s) 7 7
Bacterial Infection 7 7
Obstruction/Occlusion 7 7
Urticaria 7 7
Reaction 7 7
Local Reaction 7 7
Nausea 6 6
Dysphagia/ Odynophagia 6 6
Liver Damage/Dysfunction 6 6
Headache 6 6
Multiple Organ Failure 6 6
Thrombosis/Thrombus 6 6
Balance Problems 6 6
Hydrocephalus 6 6
Not Applicable 5 5
Pleural Effusion 5 5
Pneumonia 5 5
Foreign Body Reaction 5 5
Cardiac Arrest 5 5
Discharge 5 5
Discomfort 4 4
Burning Sensation 4 4
Stroke/CVA 4 4
Dyspnea 4 4
Hypoxia 4 4
Thromboembolism 4 4
Gastrointestinal Hemorrhage 4 4
Cerebral Edema 3 3
Abdominal Distention 3 3
Skin Disorders 3 3
Unspecified Tissue Injury 3 3
Ascites 3 3
Failure of Implant 3 3
Pneumothorax 3 3
Nerve Damage 3 3
Neuropathy 3 3
Irritation 3 3
Muscle Weakness 3 3
Chest Pain 3 3
Rupture 3 3
Uterine Perforation 3 3
Weakness 3 3
Vertigo 3 3
Renal Failure 3 3
Thrombosis 3 3
Spinal Cord Injury 3 3
Organ Dehiscence 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-05-2024
2 Ethicon, Inc. II May-22-2024
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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