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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, polyamide
Product CodeGAR
Regulation Number 878.5020
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANTARMA LLC DBA GOLNIT SUTURES
  SUBSTANTIALLY EQUIVALENT 1
KONO SEISAKUSHO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SM ENG CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNILENE S.A.C.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 100 100
2015 86 86
2016 123 123
2017 180 180
2018 541 541
2019 518 518
2020 383 383
2021 532 532
2022 546 546
2023 606 606
2024 189 189

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1833 1833
Material Separation 746 746
Adverse Event Without Identified Device or Use Problem 348 348
Detachment of Device or Device Component 220 220
Appropriate Term/Code Not Available 107 107
Material Split, Cut or Torn 74 74
Detachment Of Device Component 73 73
Device Markings/Labelling Problem 56 56
Manufacturing, Packaging or Shipping Problem 54 54
Dull, Blunt 49 49
Component Misassembled 49 49
Material Integrity Problem 47 47
Failure To Adhere Or Bond 41 41
Product Quality Problem 41 41
Defective Component 38 38
Reaction 24 24
Delivered as Unsterile Product 22 22
Patient-Device Incompatibility 21 21
Bent 20 20
Packaging Problem 20 20
Material Discolored 17 17
Device Operates Differently Than Expected 16 16
Device Misassembled During Manufacturing /Shipping 15 15
Other (for use when an appropriate device code cannot be identified) 15 15
Tear, Rip or Hole in Device Packaging 15 15
Positioning Failure 14 14
Component Incompatible 12 12
Unsealed Device Packaging 12 12
Material Twisted/Bent 11 11
Insufficient Information 11 11
Material Frayed 10 10
Inadequacy of Device Shape and/or Size 9 9
Component Missing 9 9
Device Contaminated During Manufacture or Shipping 7 7
Difficult to Open or Remove Packaging Material 5 5
Needle, separation 5 5
Crack 5 5
Fracture 4 4
Loss of or Failure to Bond 4 4
Device Or Device Fragments Location Unknown 4 4
Device Damaged Prior to Use 3 3
Unraveled Material 3 3
Material Fragmentation 3 3
Knotted 3 3
Difficult to Remove 3 3
Material Too Rigid or Stiff 2 2
Material Rupture 2 2
Nonstandard Device 2 2
Mechanical Problem 2 2
Migration or Expulsion of Device 2 2
Misassembled 2 2
Battery charger, defective 2 2
Incomplete or Missing Packaging 2 2
Contamination /Decontamination Problem 2 2
Material Deformation 2 2
Device Contamination with Chemical or Other Material 2 2
Patient Device Interaction Problem 2 2
Device Fell 1 1
Inaccurate Information 1 1
Missing Information 1 1
Unexpected Color 1 1
Incorrect Device Or Component Shipped 1 1
Mechanical Jam 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Dislodged or Dislocated 1 1
Extrusion 1 1
Out-Of-Box Failure 1 1
Malposition of Device 1 1
Obstruction of Flow 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Unknown (for use when the device problem is not known) 1 1
Microbial Contamination of Device 1 1
Contamination 1 1
Kinked 1 1
Material Erosion 1 1
Device Expiration Issue 1 1
Poor Quality Image 1 1
Leak/Splash 1 1
Device Slipped 1 1
Occlusion Within Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1564 1564
No Consequences Or Impact To Patient 1144 1144
No Known Impact Or Consequence To Patient 388 388
Unspecified Infection 147 147
Insufficient Information 117 117
Wound Dehiscence 90 90
Not Applicable 81 81
No Code Available 66 66
Post Operative Wound Infection 63 63
Pain 45 45
Hemorrhage/Bleeding 41 41
Cerebrospinal Fluid Leakage 37 37
Thrombosis/Thrombus 36 36
Foreign Body In Patient 30 30
Hematoma 30 30
Erythema 29 29
Inflammation 26 26
Swelling 24 24
Treatment with medication(s) 22 22
No Information 22 22
Abscess 21 21
Reaction 20 20
No Patient Involvement 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Necrosis 17 17
Therapy/non-surgical treatment, additional 15 15
Surgical procedure 15 15
Seroma 14 14
Local Reaction 14 14
Scar Tissue 14 14
Swelling/ Edema 14 14
Low Blood Pressure/ Hypotension 13 13
Tachycardia 12 12
Transfusion of blood products 12 12
Drainage 12 12
Fluid Discharge 11 11
Unspecified Tissue Injury 11 11
Device Embedded In Tissue or Plaque 11 11
Hypersensitivity/Allergic reaction 11 11
Impaired Healing 10 10
Meningitis 10 10
Hernia 10 10
Unintended Radiation Exposure 9 9
Failure to Anastomose 9 9
Radiation Exposure, Unintended 8 8
Skin Irritation 8 8
Irritation 7 7
Sepsis 7 7
Tissue Damage 6 6
Granuloma 6 6
Headache 6 6
Injury 6 6
Discomfort 6 6
Obstruction/Occlusion 6 6
Nonresorbable materials, unretrieved in body 5 5
Other (for use when an appropriate patient code cannot be identified) 5 5
Blood Loss 5 5
Fever 5 5
Fistula 5 5
Foreign Body Reaction 5 5
Scarring 5 5
Itching Sensation 5 5
Edema 4 4
Purulent Discharge 4 4
Surgical procedure, additional 4 4
Visual Disturbances 4 4
Numbness 4 4
Vomiting 3 3
Unknown (for use when the patient's condition is not known) 3 3
Skin Inflammation/ Irritation 3 3
Hearing Impairment 3 3
Conjunctivitis 3 3
Cellulitis 3 3
Nerve Damage 3 3
Hyperemia 3 3
Incontinence 3 3
Paralysis 3 3
Nausea 3 3
Thrombosis 2 2
Hyphema 2 2
Intraocular Pressure Increased 2 2
Laceration(s) 2 2
Muscle Spasm(s) 2 2
Bleeding 2 2
Erosion 2 2
Abdominal Pain 2 2
Foreign Body Sensation in Eye 2 2
Cyst(s) 2 2
Eye Injury 2 2
Urinary Tract Infection 2 2
Visual Impairment 2 2
Loss of Vision 2 2
Burning Sensation 2 2
Complaint, Ill-Defined 2 2
Hypoesthesia 1 1
Distress 1 1
Neck Pain 1 1
Non-union Bone Fracture 1 1
Joint Dislocation 1 1
Abnormal Vaginal Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap, Inc. II Jul-09-2014
2 C P Medical Inc. II Sep-09-2011
3 Covidien LP II Jan-29-2024
4 Covidien, LP II Feb-25-2023
5 Riverpoint Medical, LLC II Sep-08-2016
6 Teleflex Medical II May-07-2014
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