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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)
2020 2021 2022 2023 2024 2025
15 27 16 20 18 1

MDR Year MDR Reports MDR Events
2020 146 146
2021 96 96
2022 58 58
2023 271 271
2024 134 134

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 322 322
Off-Label Use 238 238
Improper or Incorrect Procedure or Method 188 188
Insufficient Information 52 52
Lack of Effect 37 37
Appropriate Term/Code Not Available 20 20
Defective Device 17 17
Use of Device Problem 15 15
Patient-Device Incompatibility 14 14
Device Contamination with Chemical or Other Material 10 10
Fail-Safe Did Not Operate 9 9
Therapeutic or Diagnostic Output Failure 6 6
Product Quality Problem 5 5
Insufficient Heating 4 4
Delivered as Unsterile Product 3 3
Device Appears to Trigger Rejection 2 2
Material Twisted/Bent 2 2
Patient Device Interaction Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Defective Component 2 2
Clumping in Device or Device Ingredient 2 2
Compatibility Problem 2 2
Contamination /Decontamination Problem 1 1
Material Fragmentation 1 1
Complete Blockage 1 1
Obstruction of Flow 1 1
Difficult or Delayed Activation 1 1
Device Markings/Labelling Problem 1 1
Failure to Cut 1 1
Output Problem 1 1
Misconnection 1 1
Device Handling Problem 1 1
Incomplete or Missing Packaging 1 1
Migration or Expulsion of Device 1 1
Explosion 1 1
Mechanical Problem 1 1
Device Dislodged or Dislocated 1 1
Break 1 1
Cross Reactivity 1 1
Human-Device Interface Problem 1 1
Loss of or Failure to Bond 1 1
Fluid/Blood Leak 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 87 87
Unspecified Infection 53 53
Abscess 45 45
No Clinical Signs, Symptoms or Conditions 41 41
Pain 41 41
Partial Hearing Loss 38 38
Hemoptysis 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Hematoma 37 37
Swelling/ Edema 32 32
Fistula 31 31
Insufficient Information 25 25
Low Blood Pressure/ Hypotension 21 21
Necrosis 20 20
Fever 19 19
Sepsis 19 19
Hearing Impairment 18 18
Post Operative Wound Infection 17 17
Hypersensitivity/Allergic reaction 16 16
Wound Dehiscence 16 16
Anaphylactic Shock 13 13
No Code Available 13 13
Pseudoaneurysm 12 12
Ischemia 12 12
Tachycardia 12 12
Total Hearing Loss 10 10
Liver Failure 10 10
Perforation 9 9
Abdominal Pain 9 9
Ulcer 9 9
Inflammation 9 9
Unspecified Hepatic or Biliary Problem 9 9
Bacterial Infection 9 9
Embolism/Embolus 8 8
Fluid Discharge 8 8
Cerebrospinal Fluid Leakage 8 8
Obstruction/Occlusion 8 8
Vomiting 7 7
Foreign Body In Patient 7 7
Local Reaction 7 7
Gastrointestinal Hemorrhage 7 7
Balance Problems 6 6
Urticaria 6 6
Nausea 6 6
No Known Impact Or Consequence To Patient 6 6
Erythema 6 6
Thrombosis/Thrombus 6 6
Dysphagia/ Odynophagia 6 6
Multiple Organ Failure 5 5
No Patient Involvement 5 5

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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