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	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	277	278
Off-Label Use	232	232
Improper or Incorrect Procedure or Method	188	188
Insufficient Information	55	55
Lack of Effect	45	45
Patient Device Interaction Problem	23	23
Appropriate Term/Code Not Available	21	21
Patient-Device Incompatibility	13	13
Device Appears to Trigger Rejection	13	13
Use of Device Problem	10	11
Device Handling Problem	10	10
Device Contamination with Chemical or Other Material	10	10
Fail-Safe Did Not Operate	9	9
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Delivered as Unsterile Product	2	2
Break	2	2
Fluid/Blood Leak	2	2
Therapeutic or Diagnostic Output Failure	2	2
Compatibility Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Difficult to Open or Remove Packaging Material	2	2
No Apparent Adverse Event	2	2
Device Dislodged or Dislocated	1	1
Structural Problem	1	1
Difficult or Delayed Activation	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Inadequate User Interface	1	1
Misassembly by Users	1	1
Output Problem	1	1
Material Fragmentation	1	2
Misconnection	1	1
Clumping in Device or Device Ingredient	1	1
Cross Reactivity	1	1
Precipitate in Device or Device Ingredient	1	1
Loss of or Failure to Bond	1	1
Defective Component	1	1
Biocompatibility	1	1
Contamination of Device Ingredient or Reagent	1	1
Device Ingredient or Reagent Problem	1	1
Device Markings/Labelling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hemorrhage/Bleeding	73	73
No Clinical Signs, Symptoms or Conditions	59	60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	46	46
Abscess	45	45
Hemoptysis	38	38
Partial Hearing Loss	38	38
Swelling/ Edema	37	37
Hematoma	35	35
Post Operative Wound Infection	31	31
Insufficient Information	30	30
Fistula	28	28
Unspecified Infection	23	23
Impaired Healing	23	23
Bacterial Infection	23	23
Pain	23	23
Necrosis	22	22
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
Fluid Discharge	10	10
Liver Failure	10	10
Embolism/Embolus	10	10
Total Hearing Loss	10	10
Tachycardia	10	10
Ulcer	9	9
Unspecified Hepatic or Biliary Problem	9	9
Inflammation	9	9
Thrombosis/Thrombus	8	8
Foreign Body Reaction	8	8
Obstruction/Occlusion	8	8
Numbness	7	7
Erythema	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	Davol, Inc.	II	Apr-21-2026
3	Ethicon, Inc.	II	May-22-2024
4	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022