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TPLC
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show TPLC since
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2021
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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
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