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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
APTOS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
CYPRIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LYDUS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MSI
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HAIDIKE MEDICAL PRODUCTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SILHOUETTE LIFT INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1802 2509
2020 1493 1493
2021 1652 1652
2022 1563 1685
2023 1814 1814
2024 1083 1083

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4541 4663
Material Separation 2989 3696
Adverse Event Without Identified Device or Use Problem 1030 1030
Detachment of Device or Device Component 553 553
Material Frayed 361 361
Material Split, Cut or Torn 137 137
Material Integrity Problem 134 134
Material Twisted/Bent 57 57
Device Markings/Labelling Problem 53 53
Delivered as Unsterile Product 36 36
Device Contaminated During Manufacture or Shipping 35 35
Dull, Blunt 35 35
Component Misassembled 34 34
Unraveled Material 31 31
Defective Component 24 24
Mechanical Problem 20 20
Positioning Failure 19 19
Insufficient Information 19 19
Appropriate Term/Code Not Available 18 18
Manufacturing, Packaging or Shipping Problem 18 18
Product Quality Problem 15 15
Tear, Rip or Hole in Device Packaging 14 14
Component Missing 10 10
Separation Problem 10 10
Packaging Problem 10 10
Off-Label Use 9 9
Component Incompatible 7 7
Migration 6 6
Patient-Device Incompatibility 6 6
Material Deformation 6 6
Difficult to Open or Remove Packaging Material 5 5
Patient Device Interaction Problem 5 5
Fracture 5 5
Material Fragmentation 5 5
Material Discolored 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Contamination /Decontamination Problem 4 4
Human-Device Interface Problem 3 3
Loss of or Failure to Bond 3 3
Material Rupture 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Slipped 3 3
Unsealed Device Packaging 3 3
Disconnection 2 2
Degraded 2 2
Microbial Contamination of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Mechanics Altered 1 1
Material Protrusion/Extrusion 1 1
Premature Separation 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Damaged by Another Device 1 1
Device Sensing Problem 1 1
Deformation Due to Compressive Stress 1 1
Dent in Material 1 1
Separation Failure 1 1
Failure to Form Staple 1 1
Defective Device 1 1
Device Damaged Prior to Use 1 1
Tip breakage 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Difficult or Delayed Positioning 1 1
Contamination 1 1
Entrapment of Device 1 1
Perivalvular Leak 1 1
Migration or Expulsion of Device 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5265 5387
No Consequences Or Impact To Patient 2458 3165
Insufficient Information 428 428
Unspecified Infection 222 222
No Known Impact Or Consequence To Patient 216 216
Hemorrhage/Bleeding 206 206
Not Applicable 199 199
Pain 157 157
Wound Dehiscence 136 136
Fistula 102 102
Hematoma 97 97
Post Operative Wound Infection 88 88
Hernia 85 85
No Code Available 81 81
Seroma 79 79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 75 75
Foreign Body In Patient 67 67
Blood Loss 67 67
Failure to Anastomose 64 64
Unspecified Tissue Injury 62 62
Obstruction/Occlusion 52 52
Unintended Radiation Exposure 50 50
Abscess 42 42
No Information 41 41
Swelling/ Edema 40 40
No Patient Involvement 37 37
Necrosis 37 37
Inflammation 36 36
Thrombosis/Thrombus 33 33
Fever 29 29
Scar Tissue 27 27
Incontinence 26 26
Sepsis 24 24
Impaired Healing 24 24
Stenosis 24 24
Erosion 23 23
Fluid Discharge 23 23
Urinary Retention 22 22
Cerebrospinal Fluid Leakage 21 21
Granuloma 19 19
Visual Impairment 19 19
Discomfort 18 18
Urinary Tract Infection 18 18
Erythema 18 18
Device Embedded In Tissue or Plaque 16 16
Adhesion(s) 14 14
Paresis 14 14
Eye Injury 13 13
Edema 12 12
Intraocular Pressure Increased 12 12
Myocardial Infarction 12 12
Pleural Effusion 12 12
Pneumothorax 12 12
Thrombosis 12 12
Pocket Erosion 11 11
Injury 11 11
Hyphema 11 11
Purulent Discharge 11 11
Perforation 10 10
Vomiting 9 9
Prolapse 9 9
Cyst(s) 9 9
Dyspnea 9 9
Atrial Fibrillation 9 9
Calcium Deposits/Calcification 9 9
Stroke/CVA 9 9
Skin Inflammation/ Irritation 9 9
Bacterial Infection 8 8
Endocarditis 8 8
Death 8 8
Headache 8 8
Respiratory Failure 8 8
Pneumonia 8 8
Tissue Damage 7 7
Perforation of Vessels 7 7
Ulcer 7 7
Ischemia 7 7
Itching Sensation 7 7
Hypersensitivity/Allergic reaction 7 7
High Blood Pressure/ Hypertension 7 7
Cardiac Arrest 7 7
Restenosis 7 7
Radiation Exposure, Unintended 7 7
Heart Failure/Congestive Heart Failure 6 6
Abdominal Pain 6 6
Laceration(s) 6 6
Foreign Body Reaction 6 6
Urinary Frequency 6 6
Swelling 6 6
Nerve Damage 6 6
Paralysis 5 5
Peritonitis 5 5
Micturition Urgency 5 5
Anemia 5 5
Mitral Valve Insufficiency/ Regurgitation 5 5
Valvular Insufficiency/ Regurgitation 4 4
Unspecified Kidney or Urinary Problem 4 4
Patient Problem/Medical Problem 4 4
Pulmonary Embolism 4 4
Dysphagia/ Odynophagia 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LP II Feb-25-2023
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