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TPLC
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show TPLC since
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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
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
235
235
Appropriate Term/Code Not Available
34
34
Patient Device Interaction Problem
27
27
Device Markings/Labelling Problem
21
21
Insufficient Information
20
20
Break
15
15
Degraded
13
13
Use of Device Problem
11
11
Detachment of Device or Device Component
6
6
Torn Material
6
6
Product Quality Problem
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
Difficult to Insert
3
3
Obstruction of Flow
3
3
Microbial Contamination of Device
2
2
Fluid Leak
2
2
Loss of or Failure to Bond
2
2
Component Incompatible
2
2
Patient-Device Incompatibility
2
2
Contamination
2
2
Tear, Rip or Hole in Device Packaging
2
2
Improper or Incorrect Procedure or Method
1
1
Detachment Of Device Component
1
1
Peeled/Delaminated
1
1
Compatibility Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Missing Information
1
1
No Apparent Adverse Event
1
1
Noise, Audible
1
1
Complete Blockage
1
1
Migration or Expulsion of Device
1
1
Expiration Date Error
1
1
Device Operates Differently Than Expected
1
1
Difficult to Open or Remove Packaging Material
1
1
Infusion or Flow Problem
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
40
40
Fever
31
31
No Known Impact Or Consequence To Patient
27
27
Hematoma
26
26
Seroma
24
24
Pain
19
19
Inflammation
17
17
Blood Loss
16
16
Hemorrhage/Bleeding
13
13
Reaction
12
12
Granuloma
11
11
Wound Dehiscence
11
11
Death
10
10
Failure to Anastomose
9
9
Anemia
8
8
Swelling
8
8
Abdominal Pain
8
8
Bacterial Infection
7
7
Paresis
7
7
Rash
5
5
Erythema
5
5
No Clinical Signs, Symptoms or Conditions
5
5
Purulent Discharge
5
5
Necrosis
5
5
Obstruction/Occlusion
5
5
Pleural Effusion
5
5
Foreign Body In Patient
5
5
Pneumonia
4
4
Paralysis
4
4
Foreign Body Reaction
4
4
Low Blood Pressure/ Hypotension
4
4
Hypersensitivity/Allergic reaction
4
4
Cyst(s)
3
3
Sepsis
3
3
Fluid Discharge
3
3
Fistula
3
3
Nerve Damage
3
3
Impaired Healing
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
Bruise/Contusion
2
2
Adhesion(s)
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
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
Asthma
1
1
Cellulitis
1
1
Hemostasis
1
1
Itching Sensation
1
1
Nausea
1
1
Post Operative Wound Infection
1
1
Weakness
1
1
Infection, Pyrogenic
1
1
Urticaria
1
1
Tissue Damage
1
1
Urinary Tract Infection
1
1
Pneumothorax
1
1
Pulmonary Edema
1
1
Local Reaction
1
1
Seizures
1
1
Swelling/ Edema
1
1
Radiation Exposure, Unintended
1
1
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