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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 2862 2862

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9510 10848
Material Separation 5793 5814
Detachment of Device or Device Component 4145 4145
Adverse Event Without Identified Device or Use Problem 3134 3622
Material Integrity Problem 524 524
Material Frayed 376 376
Material Split, Cut or Torn 265 265
Patient-Device Incompatibility 237 237
Manufacturing, Packaging or Shipping Problem 218 340
Device Markings/Labelling Problem 216 216
Unraveled Material 207 207
Appropriate Term/Code Not Available 201 201
Component Missing 157 157
Insufficient Information 136 136
Patient Device Interaction Problem 126 126
Material Twisted/Bent 120 120
Defective Component 118 118
Product Quality Problem 112 112
Component Misassembled 104 104
Positioning Failure 97 97
Tear, Rip or Hole in Device Packaging 95 95
Dull, Blunt 79 79
Difficult to Open or Remove Packaging Material 79 79
Human-Device Interface Problem 71 71
Mechanical Problem 70 70
Delivered as Unsterile Product 67 67
Packaging Problem 58 58
Device Contaminated During Manufacture or Shipping 49 49
Use of Device Problem 49 49
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 13429 13673
No Consequences Or Impact To Patient 4329 5444
Insufficient Information 1506 1506
Wound Dehiscence 1267 1267
Unspecified Infection 804 926
Inflammation 542 542
No Code Available 501 501
Pain 471 593
No Known Impact Or Consequence To Patient 461 461
Not Applicable 429 429
Post Operative Wound Infection 420 542
Foreign Body In Patient 397 519
Hemorrhage/Bleeding 340 584
Impaired Healing 333 455
Unspecified Tissue Injury 322 322
Unintended Radiation Exposure 269 269
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 237 237
No Patient Involvement 222 222
Hematoma 205 205
Abscess 196 196
Erythema 181 181
Fluid Discharge 170 170
Swelling/ Edema 167 167
No Information 162 162
Seroma 151 151
Failure to Anastomose 143 387
Pocket Erosion 136 136
Necrosis 128 128
Hernia 128 128
Granuloma 125 125
Purulent Discharge 122 122
Scar Tissue 111 111
Fistula 106 106
Obstruction/Occlusion 95 95
Fever 91 91
Hypersensitivity/Allergic reaction 88 88
Foreign Body Reaction 86 86
Skin Inflammation/ Irritation 85 85
Blood Loss 84 84
Radiation Exposure, Unintended 84 84
Device Embedded In Tissue or Plaque 80 80
Discomfort 68 68
Urinary Tract Infection 66 66
Local Reaction 64 64
Cellulitis 64 64
Swelling 59 59
Incontinence 56 56
Sepsis 43 43
Tissue Damage 41 41
Itching Sensation 39 39
Bacterial Infection 39 39
Eye Injury 38 38
Cyst(s) 37 37
Urinary Retention 34 34
Abdominal Pain 33 33
Patient Problem/Medical Problem 33 33
Laceration(s) 28 28
Tissue Breakdown 26 26
Erosion 25 25
Adhesion(s) 23 23
Ulcer 23 23
Peritonitis 21 21
Vomiting 19 19
Rash 19 19
Skin Erosion 18 18
Abnormal Vaginal Discharge 18 18
Injury 18 18
Blister 18 18
Organ Dehiscence 17 17
Eye Infections 17 17
Stenosis 17 17
Prolapse 16 16
Edema 15 15
Skin Irritation 13 13
Scarring 13 13
Perforation 13 13
Skin Infection 13 13
Reaction 12 12
Nausea 12 12
Anxiety 12 12
Chills 11 11
Visual Disturbances 11 11
Nerve Damage 11 11
Hematuria 11 11
Ptosis 11 11
Visual Impairment 10 10
Cerebrospinal Fluid Leakage 10 10
Anemia 10 10
Headache 9 9
Bowel Perforation 9 9
Abdominal Distention 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 Jun-14-2024
5 Ethicon, Inc. II Apr-12-2024
6 Ethicon, Inc. II Oct-31-2022
7 Ethicon, Inc. II May-10-2022
8 Ethicon, Inc. II Oct-16-2020
9 Ethicon, Inc. II Feb-04-2020
10 Ethicon, Inc. II Apr-12-2019
11 Gordian Surgical II Nov-03-2020
12 Riverpoint Medical, LLC II Feb-03-2021
13 Riverpoint Medical, LLC II Oct-01-2020
14 SURGICAL SPECIALTIES II Apr-12-2024
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