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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, surgical, absorbable, polydioxanone
Product CodeNEW
Regulation Number 878.4840
Device Class 2


Premarket Reviews
ManufacturerDecision
DEMETECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 3
FOOSIN MEDICAL SUPPLIES INC., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANS BIOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HYUNDAE MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDITIME CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PDO MAX, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 1122 1122
2020 1010 1010
2021 1464 1830
2022 1537 2757
2023 1975 1975
2024 527 527

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4224 4956
Material Separation 1570 1570
Adverse Event Without Identified Device or Use Problem 1051 1295
Material Integrity Problem 270 270
Positioning Failure 155 155
Detachment of Device or Device Component 109 353
Patient Device Interaction Problem 100 222
Migration 65 65
Material Frayed 63 63
Positioning Problem 52 52
Defective Component 44 44
Appropriate Term/Code Not Available 40 40
Device Markings/Labelling Problem 39 39
Material Protrusion/Extrusion 35 157
Component Misassembled 33 33
Material Split, Cut or Torn 32 32
Tear, Rip or Hole in Device Packaging 31 31
Material Twisted/Bent 26 148
Migration or Expulsion of Device 25 25
Delivered as Unsterile Product 19 19
Device Contaminated During Manufacture or Shipping 18 18
Manufacturing, Packaging or Shipping Problem 17 17
Difficult to Open or Remove Packaging Material 15 15
Expulsion 12 12
Device Appears to Trigger Rejection 12 12
Component Missing 9 9
Inadequacy of Device Shape and/or Size 7 7
Device Fell 7 7
Patient-Device Incompatibility 6 6
Material Fragmentation 6 6
Material Discolored 6 6
Entrapment of Device 6 6
Component Incompatible 6 6
Packaging Problem 5 5
Insufficient Information 5 5
Degraded 4 4
Difficult or Delayed Positioning 4 4
Loss of or Failure to Bond 4 4
Loose or Intermittent Connection 3 3
Use of Device Problem 3 3
Dull, Blunt 3 3
Product Quality Problem 3 3
Material Deformation 3 3
Separation Problem 2 2
Noise, Audible 2 124
Separation Failure 2 2
Incomplete or Missing Packaging 2 2
Device Slipped 2 2
Difficult to Remove 2 2
Material Rupture 2 2
Unsealed Device Packaging 2 2
Nonstandard Device 2 2
Crack 2 2
Fracture 2 124
Material Disintegration 1 1
Mechanical Problem 1 1
Melted 1 1
Leak/Splash 1 1
Peeled/Delaminated 1 1
Inadequate or Insufficient Training 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Dent in Material 1 1
Difficult or Delayed Separation 1 1
Missing Information 1 1
Device Contamination with Chemical or Other Material 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4400 4888
No Consequences Or Impact To Patient 1572 1572
Wound Dehiscence 487 731
Unspecified Infection 316 438
Not Applicable 193 193
Pain 186 186
Insufficient Information 185 307
Hemorrhage/Bleeding 112 112
Inflammation 100 100
Hernia 92 92
Hematoma 88 88
Abscess 85 85
Failure to Anastomose 84 84
Foreign Body In Patient 76 320
Post Operative Wound Infection 73 195
Fistula 71 71
No Code Available 63 63
Obstruction/Occlusion 56 56
Impaired Healing 56 178
Erythema 56 56
Discomfort 55 55
Seroma 53 53
Fluid Discharge 53 175
Unspecified Tissue Injury 51 51
Swelling/ Edema 49 49
Purulent Discharge 49 49
Pocket Erosion 48 48
Hypersensitivity/Allergic reaction 45 45
Skin Inflammation/ Irritation 44 44
Necrosis 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 163
No Known Impact Or Consequence To Patient 40 40
Fever 36 36
Foreign Body Reaction 34 34
Scar Tissue 32 32
Sepsis 29 29
Blood Loss 28 28
Nodule 25 25
Granuloma 24 24
Itching Sensation 22 22
Urinary Tract Infection 22 22
Rupture 20 20
Incontinence 20 20
Ulcer 19 19
Local Reaction 18 18
Swelling 16 16
Joint Dislocation 16 16
Cellulitis 13 13
Adhesion(s) 13 13
Thrombosis/Thrombus 12 12
Urinary Retention 11 11
Nausea 11 11
Pleural Effusion 11 11
Paresis 11 11
Abdominal Pain 10 10
Device Embedded In Tissue or Plaque 10 10
Loss of Range of Motion 9 9
Erosion 8 8
No Patient Involvement 8 8
Vomiting 7 7
Bacterial Infection 7 7
Pneumonia 7 7
Perforation 7 7
Blister 7 7
Pneumothorax 6 6
Rash 5 5
Ischemia 5 5
Micturition Urgency 5 5
Dysphagia/ Odynophagia 5 5
Bruise/Contusion 5 5
Peritonitis 5 5
Skin Irritation 5 5
Abdominal Distention 5 5
Needle Stick/Puncture 5 5
Muscle/Tendon Damage 5 5
Respiratory Failure 4 4
Dizziness 4 4
Death 4 4
Failure of Implant 4 126
Muscular Rigidity 4 4
Myocardial Infarction 3 3
Damage to Ligament(s) 3 3
Nerve Damage 3 3
Headache 3 3
Bone Fracture(s) 3 3
Diarrhea 3 3
Cerebrospinal Fluid Leakage 3 3
Anemia 3 3
Arthritis 3 3
Injury 3 3
Thrombosis 3 3
Septic Shock 3 3
Neck Pain 3 3
Prolapse 3 3
Retroperitoneal Hemorrhage 3 3
Unspecified Kidney or Urinary Problem 3 3
Breast Discomfort/Pain 3 3
Eye Pain 2 2
Drug Resistant Bacterial Infection 2 2
Restenosis 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
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