TPLC - Total Product Life Cycle

• Device: agent, absorbable hemostatic, non-collagen based
• Regulation Description: Absorbable hemostatic agent and dressing.
• Product Code: LMG
• Regulation Number: 878.4490
• Device Class: 3

Premarket Approvals (PMA)
2016	2017	2018	2019	2020	2021
9	3	6	19	11	0

MDR Year	MDR Reports	MDR Events
2016	2	2
2017	30	30
2018	84	84
2019	120	120
2020	173	173
2021	27	27

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	258	258
Appropriate Term/Code Not Available	36	36
Patient Device Interaction Problem	27	27
Device Markings/Labelling Problem	24	24
Insufficient Information	20	20
Break	15	15
Degraded	13	13
Use of Device Problem	11	11
Product Quality Problem	6	6
Torn Material	6	6
Detachment of Device or Device Component	6	6
Unsealed Device Packaging	5	5
Incorrect, Inadequate or Imprecise Resultor Readings	4	4
Contamination /Decontamination Problem	4	4
Material Integrity Problem	4	4
Obstruction of Flow	3	3
Difficult to Insert	3	3
Fluid Leak	2	2
Component Incompatible	2	2
Contamination	2	2
Microbial Contamination of Device	2	2
Tear, Rip or Hole in Device Packaging	2	2
Loss of or Failure to Bond	2	2
Patient-Device Incompatibility	2	2
Expiration Date Error	1	1
Device Operates Differently Than Expected	1	1
Difficult to Open or Remove Packaging Material	1	1
Compatibility Problem	1	1
Infusion or Flow Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Noise, Audible	1	1
No Apparent Adverse Event	1	1
Improper or Incorrect Procedure or Method	1	1
Peeled/Delaminated	1	1
Complete Blockage	1	1
Detachment Of Device Component	1	1
Migration or Expulsion of Device	1	1
Delivered as Unsterile Product	1	1
Missing Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	113	113
Not Applicable	80	80
No Code Available	51	51
No Consequences Or Impact To Patient	49	49
Abscess	41	41
Fever	31	31
No Known Impact Or Consequence To Patient	27	27
Hematoma	26	26
Seroma	25	25
Pain	20	20
Inflammation	17	17
Hypersensitivity/Allergic reaction	16	16
Blood Loss	16	16
Hemorrhage/Bleeding	14	14
Asthma	13	13
Hypoxia	13	13
Dyspnea	13	13
Reaction	12	12
Granuloma	11	11
Wound Dehiscence	11	11
Failure to Anastomose	10	10
Death	10	10
No Clinical Signs, Symptoms or Conditions	9	9
Anemia	8	8
Swelling	8	8
Abdominal Pain	8	8
Bacterial Infection	7	7
Paresis	7	7
Sepsis	7	7
Rash	5	5
Erythema	5	5
Purulent Discharge	5	5
Necrosis	5	5
Pleural Effusion	5	5
Obstruction/Occlusion	5	5
Foreign Body In Patient	5	5
Impaired Healing	4	4
Pneumonia	4	4
Paralysis	4	4
Foreign Body Reaction	4	4
Low Blood Pressure/ Hypotension	4	4
Cyst(s)	3	3
Fluid Discharge	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Fistula	3	3
Nerve Damage	3	3
Visual Impairment	3	3
No Patient Involvement	3	3
No Information	2	2
Vomiting	2	2
Injury	2	2
Headache	2	2
Edema	2	2
Adhesion(s)	2	2
Bruise/Contusion	2	2
Skin Irritation	2	2
Cerebrospinal Fluid Leakage	2	2
Burn(s)	1	1
Pulmonary Embolism	1	1
Air Embolism	1	1
Airway Obstruction	1	1
Exsanguination	1	1
High Blood Pressure/ Hypertension	1	1
Skin Discoloration	1	1
Hypoesthesia	1	1
Numbness	1	1
Respiratory Failure	1	1
Hematuria	1	1
Renal Failure	1	1
Irritation	1	1
Abnormal Vaginal Discharge	1	1
Vaginal Mucosa Damage	1	1
Chills	1	1
Cramp(s)	1	1
Multiple Organ Failure	1	1
Cellulitis	1	1
Hemostasis	1	1
Itching Sensation	1	1
Nausea	1	1
Tissue Damage	1	1
Urinary Tract Infection	1	1
Weakness	1	1
Infection, Pyrogenic	1	1
Urticaria	1	1
Pneumothorax	1	1
Pulmonary Edema	1	1
Local Reaction	1	1
Seizures	1	1
Radiation Exposure, Unintended	1	1
Post Operative Wound Infection	1	1
Swelling/ Edema	1	1