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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device suture, surgical, absorbable, polydioxanone
Product CodeNEW
Regulation Number 878.4840
Device Class 2


Premarket Reviews
ManufacturerDecision
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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