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TPLC
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Device
suture, surgical, absorbable, polydioxanone
Product Code
NEW
Regulation Number
878.4840
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEMETECH CORPORATION
SUBSTANTIALLY EQUIVALENT
2
ETHICON, INC.
SUBSTANTIALLY EQUIVALENT
3
FEELTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
FOOSIN MEDICAL SUPPLIES INC., LTD.
SUBSTANTIALLY EQUIVALENT
1
HANS BIOMED CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDITIME CO., LTD
SUBSTANTIALLY EQUIVALENT
1
OV WORLD CO., LTD
SUBSTANTIALLY EQUIVALENT
1
PDO MAX, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
898
898
2019
1122
1122
2020
1010
1010
2021
1464
1830
2022
1537
2757
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3447
4179
Material Separation
1074
1074
Adverse Event Without Identified Device or Use Problem
819
1063
Material Integrity Problem
146
146
Detachment of Device or Device Component
106
350
Detachment Of Device Component
92
92
Positioning Failure
73
73
Appropriate Term/Code Not Available
67
67
Positioning Problem
59
59
Material Frayed
54
54
Insufficient Information
36
36
Tear, Rip or Hole in Device Packaging
34
34
Device Markings/Labelling Problem
33
33
Device Operates Differently Than Expected
28
28
Component Misassembled
27
27
Material Split, Cut or Torn
20
20
Defective Component
20
20
Patient-Device Incompatibility
16
16
Failure To Adhere Or Bond
16
16
Material Twisted/Bent
14
136
Manufacturing, Packaging or Shipping Problem
12
12
Component Incompatible
12
12
Loss of or Failure to Bond
10
10
Material Protrusion/Extrusion
10
132
Delivered as Unsterile Product
9
9
Device Contaminated During Manufacture or Shipping
8
8
Device Fell
8
8
Migration
8
8
Inadequacy of Device Shape and/or Size
7
7
Component Missing
7
7
Migration or Expulsion of Device
6
6
Material Discolored
5
5
Failure to Form Staple
5
5
Patient Device Interaction Problem
5
127
Material Fragmentation
4
4
Entrapment of Device
4
4
Leak/Splash
4
4
Degraded
4
4
Loose or Intermittent Connection
3
3
Material Erosion
3
3
Fracture
3
125
Out-Of-Box Failure
3
3
Dull, Blunt
3
3
Difficult to Open or Remove Packaging Material
3
3
Device Dislodged or Dislocated
2
2
Incorrect Device Or Component Shipped
2
2
Material Deformation
2
2
Separation Failure
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Incomplete or Missing Packaging
2
2
Device Slipped
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Nonstandard Device
2
2
Unsealed Device Packaging
2
2
Product Quality Problem
2
2
Difficult to Remove
2
2
Air Leak
2
2
No Apparent Adverse Event
2
2
Noise, Audible
2
124
Separation Problem
1
1
Missing Information
1
1
Contamination
1
1
Crack
1
1
Material Disintegration
1
1
Mechanical Problem
1
1
Melted
1
1
Material Rupture
1
1
Device Appears to Trigger Rejection
1
1
Peeled/Delaminated
1
1
Device Issue
1
1
Difficult to Open or Close
1
1
Malposition of Device
1
1
Contamination of Device Ingredient or Reagent
1
1
Microbial Contamination of Device
1
1
Cut In Material
1
1
Dent in Material
1
1
Extrusion
1
1
Device Contamination with Chemical or Other Material
1
1
Mechanical Jam
1
1
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Packaging Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2494
2982
No Consequences Or Impact To Patient
2157
2157
Not Applicable
384
384
Wound Dehiscence
379
623
Unspecified Infection
248
370
No Code Available
138
138
Pain
130
130
Post Operative Wound Infection
104
226
Insufficient Information
85
207
Hemorrhage/Bleeding
82
83
Failure to Anastomose
82
82
Abscess
79
79
Hematoma
77
77
No Known Impact Or Consequence To Patient
75
75
Fistula
74
74
Hernia
72
72
Inflammation
69
69
Seroma
54
54
Foreign Body In Patient
52
296
Obstruction/Occlusion
49
49
Blood Loss
42
42
Unspecified Tissue Injury
42
42
Impaired Healing
38
160
Foreign Body Reaction
34
34
Fever
33
33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
32
154
Necrosis
31
31
Hypersensitivity/Allergic reaction
30
30
Sepsis
30
31
Erythema
30
30
Pocket Erosion
29
29
Fluid Discharge
29
151
Swelling/ Edema
28
28
Purulent Discharge
25
25
Incontinence
23
23
Urinary Tract Infection
22
22
Discomfort
20
20
Swelling
19
19
Granuloma
19
19
Scar Tissue
18
18
Ulcer
15
15
Urinary Retention
13
13
Joint Dislocation
12
12
Adhesion(s)
11
11
Erosion
11
11
Local Reaction
10
10
Skin Inflammation/ Irritation
10
10
Thrombosis/Thrombus
9
9
No Patient Involvement
9
9
Paresis
9
9
Nausea
9
9
Cellulitis
9
9
Abdominal Pain
9
9
Pneumonia
8
8
Itching Sensation
8
8
Pleural Effusion
7
7
Loss of Range of Motion
7
7
Death
7
7
Device Embedded In Tissue or Plaque
7
7
Skin Irritation
7
7
Vomiting
5
5
Thrombosis
5
5
Peritonitis
5
5
Abdominal Distention
5
5
Muscle/Tendon Damage
5
5
Pneumothorax
5
5
Ischemia
5
5
Micturition Urgency
4
4
Perforation
4
4
Muscular Rigidity
4
4
Rash
4
4
Bacterial Infection
4
4
Blister
4
4
Respiratory Failure
4
4
Injury
4
4
Abnormal Vaginal Discharge
4
4
Tissue Damage
3
3
Deformity/ Disfigurement
3
3
Stenosis
3
3
Dizziness
3
3
No Information
3
3
Dysphagia/ Odynophagia
3
3
Edema
3
3
Anemia
3
3
Septic Shock
3
3
Myocardial Infarction
3
3
Nerve Damage
3
3
Damage to Ligament(s)
2
2
Scarring
2
2
Renal Failure
2
2
Arthritis
2
2
Bruise/Contusion
2
2
Calcium Deposits/Calcification
2
2
Bone Fracture(s)
2
2
Fatigue
2
2
Fibrosis
2
2
Restenosis
2
2
Reaction
2
2
Respiratory Tract Infection
2
2
Urinary Frequency
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Ethicon, Inc.
II
Dec-14-2022
2
Ethicon, Inc.
II
Sep-20-2022
3
Ethicon, Inc.
II
Feb-06-2020
4
Ethicon, Inc.
II
Oct-04-2019
5
Ethicon, Inc.
II
Apr-12-2019
6
Ethicon, Inc.
II
Jul-24-2018
7
Ethicon, Inc.
II
Apr-10-2018
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