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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 2489 2489

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9383 10721
Material Separation 5695 5716
Detachment of Device or Device Component 4075 4075
Adverse Event Without Identified Device or Use Problem 3078 3566
Material Integrity Problem 517 517
Material Frayed 375 375
Material Split, Cut or Torn 262 262
Patient-Device Incompatibility 230 230
Manufacturing, Packaging or Shipping Problem 216 338
Device Markings/Labelling Problem 215 215
Unraveled Material 206 206
Appropriate Term/Code Not Available 198 198
Component Missing 151 151
Insufficient Information 136 136
Patient Device Interaction Problem 122 122
Material Twisted/Bent 118 118
Product Quality Problem 110 110
Defective Component 105 105
Component Misassembled 103 103
Positioning Failure 97 97
Tear, Rip or Hole in Device Packaging 95 95
Dull, Blunt 79 79
Difficult to Open or Remove Packaging Material 77 77
Human-Device Interface Problem 71 71
Mechanical Problem 66 66
Delivered as Unsterile Product 66 66
Packaging Problem 58 58
Use of Device Problem 49 49
Device Contaminated During Manufacture or Shipping 47 47
Device Appears to Trigger Rejection 46 46
Device Slipped 42 42
Component or Accessory Incompatibility 36 36
Material Deformation 22 22
Difficult to Remove 22 22
Component Incompatible 21 21
Material Discolored 20 20
Degraded 19 19
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
Separation Problem 10 10
Material Too Soft/Flexible 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
Failure to Fire 5 5
Separation Failure 5 5
Mechanics Altered 5 5
Migration 5 5
Device Fell 5 249
Inaccurate Information 4 4
Missing Information 4 4
Therapeutic or Diagnostic Output Failure 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
Misfire 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
Noise, Audible 1 1
No Apparent Adverse Event 1 1
Mechanical Jam 1 1
Unexpected Color 1 1
Extra Components 1 1
Failure to Advance 1 1
Expiration Date Error 1 1
Improper or Incorrect Procedure or Method 1 1
Incomplete or Missing Packaging 1 1
Deformation Due to Compressive Stress 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 13172 13416
No Consequences Or Impact To Patient 4329 5444
Insufficient Information 1473 1473
Wound Dehiscence 1242 1242
Unspecified Infection 792 914
Inflammation 528 528
No Code Available 501 501
Pain 463 585
No Known Impact Or Consequence To Patient 461 461
Not Applicable 429 429
Post Operative Wound Infection 419 541
Foreign Body In Patient 385 507
Hemorrhage/Bleeding 333 577
Impaired Healing 325 447
Unspecified Tissue Injury 316 316
Unintended Radiation Exposure 259 259
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 237 237
No Patient Involvement 222 222
Hematoma 203 203
Abscess 195 195
Erythema 179 179
Fluid Discharge 168 168
No Information 162 162
Swelling/ Edema 157 157
Seroma 150 150
Failure to Anastomose 141 385
Necrosis 128 128
Pocket Erosion 127 127
Granuloma 124 124
Hernia 123 123
Purulent Discharge 120 120
Fistula 104 104
Scar Tissue 100 100
Obstruction/Occlusion 94 94
Fever 90 90
Foreign Body Reaction 86 86
Blood Loss 84 84
Radiation Exposure, Unintended 84 84
Skin Inflammation/ Irritation 84 84
Hypersensitivity/Allergic reaction 83 83
Device Embedded In Tissue or Plaque 80 80
Discomfort 65 65
Urinary Tract Infection 65 65
Cellulitis 61 61
Swelling 59 59
Incontinence 56 56
Local Reaction 52 52
Sepsis 43 43
Tissue Damage 41 41
Itching Sensation 38 38
Eye Injury 38 38
Cyst(s) 37 37
Urinary Retention 34 34
Abdominal Pain 33 33
Patient Problem/Medical Problem 33 33
Bacterial Infection 32 32
Erosion 25 25
Laceration(s) 25 25
Adhesion(s) 23 23
Tissue Breakdown 23 23
Ulcer 22 22
Peritonitis 21 21
Injury 18 18
Abnormal Vaginal Discharge 18 18
Vomiting 18 18
Rash 18 18
Skin Erosion 18 18
Stenosis 17 17
Eye Infections 17 17
Organ Dehiscence 17 17
Prolapse 16 16
Blister 16 16
Edema 15 15
Skin Irritation 13 13
Scarring 13 13
Perforation 13 13
Skin Infection 13 13
Reaction 12 12
Anxiety 12 12
Chills 11 11
Nausea 11 11
Nerve Damage 11 11
Visual Disturbances 11 11
Hematuria 11 11
Ptosis 11 11
Visual Impairment 10 10
Cerebrospinal Fluid Leakage 10 10
Anemia 10 10
Headache 9 9
Abdominal Distention 9 9
Bowel Perforation 9 9
Fibrosis 8 8
Muscle/Tendon Damage 8 8
Burning Sensation 8 8
Urinary Frequency 7 7
Shock 7 7
Micturition Urgency 7 7
Fatigue 7 7
Hyphema 7 7
Dysphagia/ Odynophagia 7 7

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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