TPLC - Total Product Life Cycle

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Device	agent, absorbable hemostatic, collagen based
Regulation Description	Absorbable hemostatic agent and dressing.
Product Code	LMF
Regulation Number	878.4490
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
27	16	20	18	16	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	269	270
Off-Label Use	224	224
Improper or Incorrect Procedure or Method	187	187
Insufficient Information	53	53
Lack of Effect	40	40
Appropriate Term/Code Not Available	21	21
Patient Device Interaction Problem	16	16
Patient-Device Incompatibility	13	13
Device Appears to Trigger Rejection	13	13
Use of Device Problem	10	11
Fail-Safe Did Not Operate	9	9
Device Contamination with Chemical or Other Material	9	9
Device Handling Problem	7	7
Compatibility Problem	2	2
Break	2	2
Therapeutic or Diagnostic Output Failure	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Delivered as Unsterile Product	2	2
Fluid/Blood Leak	2	2
Cross Reactivity	1	1
Device Ingredient or Reagent Problem	1	1
Output Problem	1	1
Device Markings/Labelling Problem	1	1
Clumping in Device or Device Ingredient	1	1
Defective Component	1	1
Material Integrity Problem	1	1
Material Fragmentation	1	2
Precipitate in Device or Device Ingredient	1	1
Difficult or Delayed Activation	1	1
Material Twisted/Bent	1	1
Misconnection	1	1
Misassembly by Users	1	1
Contamination of Device Ingredient or Reagent	1	1
Device Dislodged or Dislocated	1	1
Loss of or Failure to Bond	1	1
Biocompatibility	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hemorrhage/Bleeding	67	67
No Clinical Signs, Symptoms or Conditions	52	53
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	45	45
Abscess	45	45
Hemoptysis	38	38
Partial Hearing Loss	38	38
Swelling/ Edema	36	36
Hematoma	30	30
Fistula	28	28
Insufficient Information	28	28
Post Operative Wound Infection	27	27
Unspecified Infection	23	23
Bacterial Infection	23	23
Pain	23	23
Necrosis	22	22
Impaired Healing	21	21
Fever	20	20
Sepsis	19	19
Hearing Impairment	18	18
Hypersensitivity/Allergic reaction	17	17
Wound Dehiscence	17	17
Low Blood Pressure/ Hypotension	17	17
Pseudoaneurysm	12	12
Anaphylactic Shock	12	12
Liver Failure	10	10
Total Hearing Loss	10	10
Embolism/Embolus	10	10
Tachycardia	10	10
Ulcer	9	9
Unspecified Hepatic or Biliary Problem	9	9
Fluid Discharge	9	9
Inflammation	9	9
Thrombosis/Thrombus	8	8
Obstruction/Occlusion	8	8
Numbness	7	7
Erythema	7	7
Foreign Body Reaction	7	7
Multiple Organ Failure	7	7
Local Reaction	7	7
Perforation	7	7
Ischemia	7	7
Gastrointestinal Hemorrhage	7	7
Abdominal Pain	6	6
Dysphagia/ Odynophagia	6	6
Urticaria	6	6
Cerebrospinal Fluid Leakage	6	6
Balance Problems	6	6
Pneumonia	5	5
Cerebral Edema	5	5
Vomiting	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