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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 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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