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TPLC
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show TPLC since
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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
2
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
900
900
2019
1122
1122
2020
1010
1010
2021
1464
1830
2022
1537
2757
2023
1662
1662
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
4271
5003
Material Separation
1419
1419
Adverse Event Without Identified Device or Use Problem
1012
1256
Material Integrity Problem
258
258
Detachment of Device or Device Component
131
375
Positioning Failure
130
130
Patient Device Interaction Problem
93
215
Detachment Of Device Component
92
92
Appropriate Term/Code Not Available
69
69
Material Frayed
66
66
Migration
63
63
Positioning Problem
59
59
Device Markings/Labelling Problem
40
40
Tear, Rip or Hole in Device Packaging
38
38
Insufficient Information
37
37
Material Protrusion/Extrusion
36
158
Defective Component
34
34
Component Misassembled
31
31
Material Split, Cut or Torn
30
30
Device Operates Differently Than Expected
28
28
Migration or Expulsion of Device
25
25
Material Twisted/Bent
24
146
Device Contaminated During Manufacture or Shipping
17
17
Patient-Device Incompatibility
16
16
Failure To Adhere Or Bond
16
16
Delivered as Unsterile Product
15
15
Manufacturing, Packaging or Shipping Problem
13
13
Component Incompatible
12
12
Difficult to Open or Remove Packaging Material
11
11
Expulsion
11
11
Loss of or Failure to Bond
10
10
Device Appears to Trigger Rejection
9
9
Component Missing
8
8
Device Fell
8
8
Inadequacy of Device Shape and/or Size
7
7
Material Discolored
6
6
Entrapment of Device
6
6
Failure to Form Staple
5
5
Leak/Splash
4
4
Loose or Intermittent Connection
4
4
Degraded
4
4
Material Fragmentation
4
4
Product Quality Problem
3
3
Material Rupture
3
3
Use of Device Problem
3
3
Material Erosion
3
3
Fracture
3
125
Out-Of-Box Failure
3
3
Dull, Blunt
3
3
Material Deformation
3
3
Packaging Problem
3
3
Separation Failure
2
2
Incorrect Device Or Component Shipped
2
2
Device Dislodged or Dislocated
2
2
Incomplete or Missing Packaging
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Improper or Incorrect Procedure or Method
2
2
Device Slipped
2
2
Air Leak
2
2
Nonstandard Device
2
2
Difficult to Remove
2
2
Unsealed Device Packaging
2
2
No Apparent Adverse Event
2
2
Noise, Audible
2
124
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Separation Problem
1
1
Missing Information
1
1
Peeled/Delaminated
1
1
Inadequate or Insufficient Training
1
1
Material Disintegration
1
1
Mechanical Problem
1
1
Melted
1
1
Difficult or Delayed Positioning
1
1
Contamination
1
1
Crack
1
1
Contamination of Device Ingredient or Reagent
1
1
Defective Device
1
1
Malposition of Device
1
1
Microbial Contamination of Device
1
1
Device Issue
1
1
Cut In Material
1
1
Dent in Material
1
1
Difficult to Open or Close
1
1
Extrusion
1
1
Device Contamination with Chemical or Other Material
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3742
4230
No Consequences Or Impact To Patient
2157
2157
Wound Dehiscence
519
763
Not Applicable
384
384
Unspecified Infection
330
452
Pain
185
185
Insufficient Information
147
269
No Code Available
138
138
Post Operative Wound Infection
107
229
Inflammation
102
102
Hemorrhage/Bleeding
100
101
Hernia
97
97
Abscess
96
96
Hematoma
93
93
Failure to Anastomose
92
92
Fistula
84
84
No Known Impact Or Consequence To Patient
75
75
Foreign Body In Patient
69
313
Seroma
59
59
Obstruction/Occlusion
58
58
Discomfort
57
57
Erythema
52
52
Fluid Discharge
51
173
Unspecified Tissue Injury
49
49
Impaired Healing
46
168
Pocket Erosion
44
44
Hypersensitivity/Allergic reaction
43
43
Purulent Discharge
43
43
Swelling/ Edema
43
43
Necrosis
42
42
Blood Loss
42
42
Skin Inflammation/ Irritation
40
40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
39
161
Fever
37
37
Foreign Body Reaction
35
35
Scar Tissue
31
31
Sepsis
30
31
Urinary Tract Infection
26
26
Granuloma
24
24
Incontinence
24
24
Nodule
21
21
Rupture
20
20
Swelling
19
19
Local Reaction
18
18
Itching Sensation
17
17
Ulcer
15
15
Joint Dislocation
15
15
Urinary Retention
14
14
Adhesion(s)
14
14
Erosion
12
12
Nausea
11
11
Pleural Effusion
10
10
Abdominal Pain
10
10
Cellulitis
10
10
Device Embedded In Tissue or Plaque
10
10
Thrombosis/Thrombus
10
10
No Patient Involvement
9
9
Paresis
9
9
Pneumonia
8
8
Loss of Range of Motion
7
7
Death
7
7
Skin Irritation
7
7
Vomiting
7
7
Bacterial Infection
6
6
Pneumothorax
6
6
Perforation
5
5
Ischemia
5
5
Bruise/Contusion
5
5
Dysphagia/ Odynophagia
5
5
Peritonitis
5
5
Thrombosis
5
5
Abdominal Distention
5
5
Needle Stick/Puncture
5
5
Blister
5
5
Muscle/Tendon Damage
5
5
Respiratory Failure
4
4
Injury
4
4
Abnormal Vaginal Discharge
4
4
Dizziness
4
4
Micturition Urgency
4
4
Rash
4
4
Muscular Rigidity
4
4
Myocardial Infarction
3
3
Damage to Ligament(s)
3
3
Nerve Damage
3
3
Failure of Implant
3
125
Diarrhea
3
3
Edema
3
3
Calcium Deposits/Calcification
3
3
Anemia
3
3
Deformity/ Disfigurement
3
3
Stenosis
3
3
Tissue Damage
3
3
Septic Shock
3
3
Neck Pain
3
3
No Information
3
3
Breast Discomfort/Pain
3
3
Restenosis
2
2
Respiratory Tract Infection
2
2
Reaction
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Ethicon, Inc.
II
May-10-2023
2
Ethicon, Inc.
II
Dec-14-2022
3
Ethicon, Inc.
II
Sep-20-2022
4
Ethicon, Inc.
II
Feb-06-2020
5
Ethicon, Inc.
II
Oct-04-2019
6
Ethicon, Inc.
II
Apr-12-2019
7
Ethicon, Inc.
II
Jul-24-2018
8
Ethicon, Inc.
II
Apr-10-2018
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