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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
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  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 681 681

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4280 5012
Material Separation 1617 1617
Adverse Event Without Identified Device or Use Problem 1079 1323
Material Integrity Problem 274 274
Positioning Failure 162 162
Detachment of Device or Device Component 110 354
Patient Device Interaction Problem 100 222
Migration 65 65
Material Frayed 65 65
Positioning Problem 52 52
Defective Component 44 44
Appropriate Term/Code Not Available 40 40
Device Markings/Labelling Problem 39 39
Component Misassembled 37 37
Material Protrusion/Extrusion 35 157
Material Split, Cut or Torn 33 33
Tear, Rip or Hole in Device Packaging 31 31
Material Twisted/Bent 28 150
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 18 18
Difficult to Open or Remove Packaging Material 16 16
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
Degraded 5 5
Packaging Problem 5 5
Insufficient Information 5 5
Separation Problem 5 5
Material Deformation 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
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
Therapeutic or Diagnostic Output Failure 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4521 5009
No Consequences Or Impact To Patient 1572 1572
Wound Dehiscence 500 744
Unspecified Infection 332 454
Insufficient Information 194 316
Not Applicable 193 193
Pain 188 188
Hemorrhage/Bleeding 112 112
Inflammation 101 101
Hernia 95 95
Hematoma 90 90
Abscess 87 87
Failure to Anastomose 84 84
Foreign Body In Patient 76 320
Post Operative Wound Infection 76 198
Fistula 74 74
No Code Available 63 63
Obstruction/Occlusion 59 59
Impaired Healing 58 180
Discomfort 57 57
Erythema 57 57
Seroma 55 55
Fluid Discharge 53 175
Unspecified Tissue Injury 52 52
Purulent Discharge 51 51
Swelling/ Edema 49 49
Pocket Erosion 48 48
Hypersensitivity/Allergic reaction 45 45
Skin Inflammation/ Irritation 45 45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 43 165
Necrosis 42 42
No Known Impact Or Consequence To Patient 40 40
Fever 36 36
Foreign Body Reaction 34 34
Scar Tissue 34 34
Sepsis 30 30
Blood Loss 28 28
Nodule 25 25
Granuloma 24 24
Urinary Tract Infection 23 23
Itching Sensation 22 22
Incontinence 21 21
Rupture 20 20
Ulcer 19 19
Local Reaction 18 18
Swelling 16 16
Joint Dislocation 16 16
Cellulitis 13 13
Adhesion(s) 13 13
Urinary Retention 12 12
Thrombosis/Thrombus 12 12
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
Prolapse 4 4
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
Stenosis 3 3
Injury 3 3
Thrombosis 3 3
Septic Shock 3 3
Neck Pain 3 3
Unspecified Kidney or Urinary Problem 3 3
Breast Discomfort/Pain 3 3
Retroperitoneal Hemorrhage 3 3
Eye Pain 2 2
Ischemia Stroke 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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