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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, nonabsorbable, synthetic, polypropylene
Product CodeGAW
Regulation Number 878.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANGIOTECH
  SUBSTANTIALLY EQUIVALENT 2
APTOS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ASSUT EUROPE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US, LLC
  SUBSTANTIALLY EQUIVALENT 1
CYPRIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DURA TAP LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
LSI SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LSI SOULTIONS
  SUBSTANTIALLY EQUIVALENT 1
LYDUS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MSI
  SUBSTANTIALLY EQUIVALENT 1
NOBLES MEDICAL TECHNOLOGIES II, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
ORIGAMI SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
RESORBA MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HAIDIKE MEDICAL PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SILHOUETTE LIFT INC.
  SUBSTANTIALLY EQUIVALENT 2
SM ENG CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 434 434
2015 420 420
2016 440 440
2017 413 413
2018 685 1676
2019 1802 2509
2020 1493 1493
2021 1652 1652
2022 1563 1685
2023 1814 1814
2024 779 779

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5285 6051
Material Separation 2932 3986
Adverse Event Without Identified Device or Use Problem 1157 1157
Detachment of Device or Device Component 729 729
Material Frayed 420 420
Failure To Adhere Or Bond 374 374
Material Integrity Problem 194 194
Appropriate Term/Code Not Available 167 167
Material Split, Cut or Torn 142 142
Detachment Of Device Component 114 114
Insufficient Information 79 79
Device Operates Differently Than Expected 75 75
Device Markings/Labelling Problem 74 74
Material Twisted/Bent 60 60
Dull, Blunt 43 43
Needle, separation 36 36
Unraveled Material 35 35
Delivered as Unsterile Product 34 34
Component Misassembled 34 34
Tear, Rip or Hole in Device Packaging 32 32
Device Contaminated During Manufacture or Shipping 31 31
Other (for use when an appropriate device code cannot be identified) 31 31
Bent 30 30
Patient-Device Incompatibility 29 29
Product Quality Problem 28 28
Mechanical Problem 27 27
Defective Component 27 27
Unsealed Device Packaging 25 25
Fracture 22 22
Positioning Failure 22 22
Manufacturing, Packaging or Shipping Problem 22 22
Split 20 20
Component Missing 20 20
Battery charger, defective 19 19
Device Slipped 15 15
Component Incompatible 14 14
Packaging Problem 14 14
Knotted 13 13
Material Rupture 12 12
Material Deformation 12 12
Difficult to Open or Remove Packaging Material 11 11
Migration or Expulsion of Device 11 11
Reaction 10 10
Separation Problem 10 10
Device Or Device Fragments Location Unknown 9 9
Off-Label Use 9 9
Kinked 9 9
Improper or Incorrect Procedure or Method 9 9
Loose or Intermittent Connection 8 8
Material Fragmentation 8 8
Material Erosion 8 8
Torn Material 8 8
Malposition of Device 7 7
Leak/Splash 7 7
Crack 7 7
Loss of or Failure to Bond 6 6
Disconnection 6 6
Sticking 6 6
Difficult to Remove 6 6
No Apparent Adverse Event 6 6
Migration 6 6
Patient Device Interaction Problem 5 5
Material Protrusion/Extrusion 5 5
Use of Device Problem 5 5
Component Falling 5 5
Contamination 4 4
Degraded 4 4
Coiled 4 4
Stretched 4 4
Human-Device Interface Problem 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Failure to Form Staple 4 4
Failure to Cut 4 4
Contamination /Decontamination Problem 4 4
Device Dislodged or Dislocated 3 3
Extrusion 3 3
Device Packaging Compromised 3 3
Incorrect Device Or Component Shipped 3 3
Inadequacy of Device Shape and/or Size 3 3
Misassembled 3 3
Device Inoperable 3 3
Difficult or Delayed Positioning 3 3
Partial Blockage 2 2
Entrapment of Device 2 2
Device Damaged Prior to Use 2 2
Implant extrusion 2 2
Microbial Contamination of Device 2 2
Cut In Material 2 2
Material Too Rigid or Stiff 2 2
Therapeutic or Diagnostic Output Failure 2 2
Mechanical Jam 2 2
Mechanics Altered 2 2
Compatibility Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Failure to Fire 2 2
Defective Device 1 1
Separation Failure 1 1
Physical Resistance 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5002 5124
No Consequences Or Impact To Patient 2758 4456
No Known Impact Or Consequence To Patient 1297 1298
Not Applicable 495 495
Insufficient Information 406 406
No Code Available 325 325
Unspecified Infection 325 325
Hemorrhage/Bleeding 251 251
Pain 213 213
Wound Dehiscence 211 211
No Information 164 164
Blood Loss 159 159
Hematoma 145 145
Post Operative Wound Infection 142 142
Hernia 140 141
Seroma 124 125
Fistula 123 123
Foreign Body In Patient 87 87
Failure to Anastomose 83 83
Surgical procedure 75 75
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 75 75
Abscess 72 72
Obstruction/Occlusion 67 68
Unspecified Tissue Injury 60 60
Device Embedded In Tissue or Plaque 58 58
No Patient Involvement 53 53
Death 52 52
Unintended Radiation Exposure 50 50
Inflammation 49 50
Erosion 44 44
Necrosis 44 44
Granuloma 42 42
Swelling/ Edema 38 38
Impaired Healing 37 37
Fever 36 36
Sepsis 36 37
Scar Tissue 33 33
Thrombosis/Thrombus 33 33
Stenosis 31 31
Tissue Damage 31 31
Incontinence 30 30
Urinary Retention 29 29
Organ Dehiscence 26 26
Urinary Tract Infection 25 25
Erythema 25 25
Cerebrospinal Fluid Leakage 24 24
Fluid Discharge 22 22
Visual Impairment 21 21
Thrombosis 20 20
Injury 20 20
Eye Injury 19 19
Discomfort 18 18
Foreign Body Reaction 17 17
Other (for use when an appropriate patient code cannot be identified) 17 17
Edema 16 16
Adhesion(s) 16 16
Treatment with medication(s) 16 16
Reaction 15 15
Cardiac Arrest 15 15
Purulent Discharge 14 14
Blurred Vision 14 14
Swelling 14 14
Paresis 14 14
Pleural Effusion 14 14
Myocardial Infarction 13 13
Calcium Deposits/Calcification 13 13
Bleeding 13 13
Ischemia 13 13
Surgical procedure, additional 13 13
Laceration(s) 12 12
Hypersensitivity/Allergic reaction 12 12
Dyspnea 12 12
Perforation 12 12
Pneumothorax 12 12
Vomiting 12 12
Cellulitis 11 11
Intraocular Pressure Increased 11 11
Pseudoaneurysm 11 11
Ptosis 11 11
Radiation Exposure, Unintended 11 11
Itching Sensation 10 10
High Blood Pressure/ Hypertension 10 10
Hyphema 10 10
Nonresorbable materials, unretrieved in body 10 10
Pocket Erosion 10 10
Pneumonia 10 10
Cyst(s) 9 9
Stroke/CVA 9 9
Atrial Fibrillation 9 9
Bacterial Infection 9 9
Prolapse 9 9
Respiratory Failure 8 8
Missing Value Reason 8 8
Abdominal Pain 8 8
Endocarditis 8 8
Headache 8 8
Ulcer 8 8
Peritonitis 7 7
Perforation of Vessels 7 7
Paralysis 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LP II Feb-25-2023
2 Ethicon, Inc. II Jul-17-2018
3 SSC- Surgical Specialties Corporation II Jun-21-2016
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