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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, absorbable, synthetic, polyglycolic acid
Product CodeGAM
Regulation Number 878.4493
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 2
FOOSIN MEDICAL SUPPLIES INC., LTD
  SUBSTANTIALLY EQUIVALENT 2
ORIGAMI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL INC .
  SUBSTANTIALLY EQUIVALENT 2
SAMYANG HOLDINGS CORP., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SILHOUETTE LIFT INC.
  SUBSTANTIALLY EQUIVALENT 1
SM ENG CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3564 4679
2020 3414 3414
2021 4504 4870
2022 4814 5546
2023 5072 5072
2024 1765 1765

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9126 10464
Material Separation 5559 5580
Detachment of Device or Device Component 3986 3986
Adverse Event Without Identified Device or Use Problem 2873 3361
Material Integrity Problem 511 511
Material Frayed 365 365
Material Split, Cut or Torn 252 252
Patient-Device Incompatibility 230 230
Device Markings/Labelling Problem 215 215
Manufacturing, Packaging or Shipping Problem 213 335
Unraveled Material 206 206
Appropriate Term/Code Not Available 193 193
Component Missing 147 147
Insufficient Information 123 123
Patient Device Interaction Problem 122 122
Material Twisted/Bent 117 117
Product Quality Problem 109 109
Component Misassembled 102 102
Positioning Failure 95 95
Tear, Rip or Hole in Device Packaging 94 94
Defective Component 85 85
Dull, Blunt 77 77
Human-Device Interface Problem 71 71
Difficult to Open or Remove Packaging Material 70 70
Mechanical Problem 66 66
Delivered as Unsterile Product 66 66
Packaging Problem 57 57
Device Contaminated During Manufacture or Shipping 46 46
Device Appears to Trigger Rejection 46 46
Use of Device Problem 45 45
Device Slipped 42 42
Component or Accessory Incompatibility 36 36
Difficult to Remove 22 22
Component Incompatible 21 21
Material Deformation 21 21
Degraded 19 19
Material Discolored 18 18
Material Fragmentation 18 18
Entrapment of Device 15 15
Device Contamination with Chemical or Other Material 12 12
Fracture 11 11
Nonstandard Device 11 11
Positioning Problem 11 11
Material Too Soft/Flexible 9 9
Separation Problem 9 9
Inadequacy of Device Shape and/or Size 9 9
Defective Device 9 9
Biocompatibility 8 8
Loose or Intermittent Connection 8 130
Material Disintegration 7 7
Contamination /Decontamination Problem 7 7
Difficult to Open or Close 7 7
Device Misassembled During Manufacturing /Shipping 5 5
Material Protrusion/Extrusion 5 5
Separation Failure 5 5
Failure to Fire 5 5
Device Fell 5 249
Migration 5 5
Mechanics Altered 5 5
Therapeutic or Diagnostic Output Failure 4 4
Inaccurate Information 4 4
Missing Information 4 4
Sharp Edges 3 3
Disconnection 3 3
Unsealed Device Packaging 3 3
Material Too Rigid or Stiff 3 3
Leak/Splash 2 2
Migration or Expulsion of Device 2 2
Fluid/Blood Leak 2 2
Device Damaged Prior to Use 2 2
Structural Problem 2 2
Physical Resistance/Sticking 2 2
Loosening of Implant Not Related to Bone-Ingrowth 1 1
No Apparent Adverse Event 1 1
Noise, Audible 1 1
Unexpected Color 1 1
Extra Components 1 1
Failure to Advance 1 1
Expiration Date Error 1 1
Misfire 1 1
Improper or Incorrect Procedure or Method 1 1
Incomplete or Missing Packaging 1 1
Deformation Due to Compressive Stress 1 1
Mechanical Jam 1 1
Compatibility Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loss of or Failure to Bond 1 1
Material Erosion 1 1
Difficult or Delayed Positioning 1 1
Corroded 1 1
Collapse 1 1
Material Puncture/Hole 1 1
Material Rupture 1 1
Stretched 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12722 12966
No Consequences Or Impact To Patient 4329 5444
Insufficient Information 1324 1324
Wound Dehiscence 1188 1188
Unspecified Infection 738 860
No Code Available 501 501
Inflammation 493 493
No Known Impact Or Consequence To Patient 461 461
Pain 440 562
Not Applicable 429 429
Post Operative Wound Infection 403 525
Foreign Body In Patient 375 497
Impaired Healing 318 440
Hemorrhage/Bleeding 310 554
Unspecified Tissue Injury 298 298
Unintended Radiation Exposure 253 253
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 236 236
No Patient Involvement 222 222
Abscess 193 193
Hematoma 182 182
Erythema 170 170
No Information 162 162
Fluid Discharge 162 162
Swelling/ Edema 143 143
Seroma 138 138
Failure to Anastomose 128 372
Pocket Erosion 124 124
Necrosis 120 120
Granuloma 119 119
Purulent Discharge 116 116
Hernia 108 108
Fistula 96 96
Scar Tissue 88 88
Foreign Body Reaction 84 84
Radiation Exposure, Unintended 84 84
Blood Loss 84 84
Obstruction/Occlusion 84 84
Hypersensitivity/Allergic reaction 83 83
Fever 82 82
Skin Inflammation/ Irritation 80 80
Device Embedded In Tissue or Plaque 79 79
Discomfort 64 64
Swelling 59 59
Urinary Tract Infection 57 57
Cellulitis 55 55
Local Reaction 51 51
Incontinence 51 51
Tissue Damage 41 41
Eye Injury 36 36
Itching Sensation 36 36
Sepsis 35 35
Patient Problem/Medical Problem 33 33
Bacterial Infection 32 32
Urinary Retention 31 31
Abdominal Pain 30 30
Erosion 25 25
Ulcer 22 22
Adhesion(s) 21 21
Cyst(s) 21 21
Laceration(s) 21 21
Peritonitis 20 20
Tissue Breakdown 19 19
Injury 18 18
Abnormal Vaginal Discharge 18 18
Rash 18 18
Skin Erosion 18 18
Vomiting 17 17
Stenosis 17 17
Eye Infections 17 17
Organ Dehiscence 17 17
Blister 16 16
Edema 15 15
Skin Irritation 13 13
Scarring 13 13
Skin Infection 13 13
Reaction 12 12
Anxiety 12 12
Chills 11 11
Perforation 11 11
Nausea 10 10
Visual Impairment 10 10
Cerebrospinal Fluid Leakage 10 10
Visual Disturbances 10 10
Hematuria 10 10
Ptosis 10 10
Abdominal Distention 9 9
Prolapse 9 9
Bowel Perforation 9 9
Anemia 9 9
Headache 8 8
Burning Sensation 8 8
Nerve Damage 7 7
Shock 7 7
Fatigue 7 7
Dysphagia/ Odynophagia 7 7
Muscle/Tendon Damage 7 7
Fibrosis 6 6
Multiple Organ Failure 6 6
Eye Pain 6 6
Numbness 6 6

Recalls
Manufacturer Recall Class Date Posted
1 CP Medical Inc II Dec-06-2019
2 Covidien LLC II Feb-19-2020
3 Covidien, LP II Nov-11-2022
4 Ethicon, Inc. II Apr-12-2024
5 Ethicon, Inc. II Oct-31-2022
6 Ethicon, Inc. II May-10-2022
7 Ethicon, Inc. II Oct-16-2020
8 Ethicon, Inc. II Feb-04-2020
9 Ethicon, Inc. II Apr-12-2019
10 Gordian Surgical II Nov-03-2020
11 Riverpoint Medical, LLC II Feb-03-2021
12 Riverpoint Medical, LLC II Oct-01-2020
13 SURGICAL SPECIALTIES II Apr-12-2024
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