Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
0
MDR Year
MDR Reports
MDR Events
2019
120
120
2020
173
173
2021
209
209
2022
144
144
2023
212
212
2024
40
40
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
631
631
Device Markings/Labelling Problem
61
61
Delivered as Unsterile Product
44
44
Patient-Device Incompatibility
43
43
Patient Device Interaction Problem
27
27
Appropriate Term/Code Not Available
21
21
Device Contaminated During Manufacture or Shipping
19
19
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
Device-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
158
158
No Clinical Signs, Symptoms or Conditions
133
133
Hemorrhage/Bleeding
98
98
Abscess
83
83
Fever
67
67
Not Applicable
61
61
Pain
52
52
Hematoma
48
48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
42
42
No Consequences Or Impact To Patient
38
38
Swelling/ Edema
37
37
Inflammation
36
36
Foreign Body In Patient
33
33
No Code Available
33
33
Seroma
26
26
Wound Dehiscence
25
25
Insufficient Information
23
23
Hypersensitivity/Allergic reaction
23
23
Fluid Discharge
22
22
Cerebrospinal Fluid Leakage
21
21
Nerve Damage
19
19
Foreign Body Reaction
19
19
Sepsis
18
18
Paralysis
18
18
Failure to Anastomose
15
15
Abdominal Pain
14
14
Purulent Discharge
14
14
Asthma
14
14
Dyspnea
14
14
Necrosis
13
13
Obstruction/Occlusion
13
13
Hypoxia
13
13
Blood Loss
13
13
Adhesion(s)
12
12
Reaction
11
11
Granuloma
11
11
Bacterial Infection
11
11
Skin Inflammation/ Irritation
10
10
Meningitis
10
10
Unspecified Tissue Injury
10
10
Impaired Healing
9
9
Low Blood Pressure/ Hypotension
9
9
Headache
9
9
Numbness
9
9
Erythema
8
8
Tachycardia
8
8
Pleural Effusion
8
8
Post Operative Wound Infection
7
7
Stroke/CVA
7
7
Rash
7
7
Pneumothorax
7
7
Fistula
7
7
Vomiting
7
7
Peritonitis
7
7
Erosion
6
6
Pneumonia
6
6
Swelling
6
6
Anemia
5
5
Paresis
4
4
Nausea
4
4
Solid Tumour
4
4
High Blood Pressure/ Hypertension
4
4
Respiratory Failure
4
4
Anaphylactic Shock
4
4
Bruise/Contusion
4
4
Local Reaction
3
3
Pseudoaneurysm
3
3
Renal Failure
3
3
Visual Disturbances
3
3
Itching Sensation
3
3
Hormonal Imbalance
3
3
Death
3
3
Hydrocephalus
3
3
Visual Impairment
3
3
Pulmonary Embolism
3
3
Cyst(s)
3
3
Thrombosis/Thrombus
3
3
Burn(s)
2
2
Brain Injury
2
2
Failure of Implant
2
2
Skin Discoloration
2
2
Fibrosis
2
2
Incontinence
2
2
Stenosis
2
2
Discomfort
2
2
Injury
2
2
Blister
2
2
Chest Pain
2
2
Pericarditis
2
2
Neck Pain
2
2
Cancer
2
2
Skin Irritation
2
2
Hernia
2
2
Speech Disorder
2
2
Urinary Tract Infection
2
2
Edema
2
2
Pulmonary Edema
2
2
Respiratory Tract Infection
1
1
Ptosis
1
1
Loss of Vision
1
1
-
-