TPLC - Total Product Life Cycle

• Device: agent, absorbable hemostatic, non-collagen based
• Product Code: LMG
• Regulation Number: 878.4490
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
19	11	11	9	13	2

MDR Year	MDR Reports	MDR Events
2019	120	120
2020	173	173
2021	209	209
2022	144	144
2023	212	212
2024	76	76

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	653	653
Device Markings/Labelling Problem	65	65
Patient-Device Incompatibility	47	47
Delivered as Unsterile Product	47	47
Patient Device Interaction Problem	27	27
Appropriate Term/Code Not Available	21	21
Device Contaminated During Manufacture or Shipping	21	21
Material Integrity Problem	17	17
Use of Device Problem	13	13
Insufficient Information	9	9
Device Contamination with Chemical or Other Material	5	5
Contamination /Decontamination Problem	4	4
Unsealed Device Packaging	4	4
Improper or Incorrect Procedure or Method	3	3
Tear, Rip or Hole in Device Packaging	2	2
Product Quality Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Difficult to Open or Remove Packaging Material	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Packaging Problem	1	1
Missing Information	1	1
Peeled/Delaminated	1	1
Break	1	1
Material Fragmentation	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Expiration Date Error	1	1
Incomplete or Missing Packaging	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	164	164
No Clinical Signs, Symptoms or Conditions	143	143
Hemorrhage/Bleeding	102	102
Abscess	83	83
Fever	68	68
Not Applicable	61	61
Pain	52	52
Hematoma	51	51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	42	42
Swelling/ Edema	39	39
No Consequences Or Impact To Patient	38	38
Inflammation	38	38
No Code Available	33	33
Foreign Body In Patient	33	33
Wound Dehiscence	29	29
Seroma	27	27
Insufficient Information	24	24
Fluid Discharge	23	23
Hypersensitivity/Allergic reaction	23	23
Cerebrospinal Fluid Leakage	23	23
Foreign Body Reaction	19	19
Nerve Damage	19	19
Sepsis	18	18
Paralysis	18	18
Failure to Anastomose	15	15
Abdominal Pain	14	14
Asthma	14	14
Purulent Discharge	14	14
Dyspnea	14	14
Hypoxia	13	13
Blood Loss	13	13
Impaired Healing	13	13
Obstruction/Occlusion	13	13
Necrosis	13	13
Bacterial Infection	12	12
Adhesion(s)	12	12
Granuloma	11	11
Reaction	11	11
Unspecified Tissue Injury	11	11
Skin Inflammation/ Irritation	10	10
Post Operative Wound Infection	10	10
Meningitis	10	10
Low Blood Pressure/ Hypotension	10	10
Headache	9	9
Numbness	9	9
Tachycardia	9	9
Erythema	8	8
Pleural Effusion	8	8
Pneumothorax	8	8
Pneumonia	7	7
Rash	7	7
Stroke/CVA	7	7
Fistula	7	7
Vomiting	7	7
Peritonitis	7	7
Swelling	6	6
Anemia	6	6
Erosion	6	6
Bruise/Contusion	4	4
Anaphylactic Shock	4	4
High Blood Pressure/ Hypertension	4	4
Nausea	4	4
Paresis	4	4
Visual Disturbances	4	4
Respiratory Failure	4	4
Solid Tumour	4	4
Thrombosis/Thrombus	3	3
Hormonal Imbalance	3	3
Pseudoaneurysm	3	3
Hydrocephalus	3	3
Visual Impairment	3	3
Local Reaction	3	3
Renal Failure	3	3
Itching Sensation	3	3
Failure of Implant	3	3
Incontinence	3	3
Pulmonary Embolism	3	3
Cyst(s)	3	3
Death	3	3
Chest Pain	2	2
Edema	2	2
Burn(s)	2	2
Calcium Deposits/Calcification	2	2
Pulmonary Edema	2	2
Skin Discoloration	2	2
Skin Irritation	2	2
Urinary Tract Infection	2	2
Neck Pain	2	2
Stenosis	2	2
Discomfort	2	2
Injury	2	2
Brain Injury	2	2
Hernia	2	2
Cancer	2	2
Fibrosis	2	2
Pericarditis	2	2
Speech Disorder	2	2
Blister	2	2
Ischemia Stroke	1	1
Unspecified Nervous System Problem	1	1