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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 473 473

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8650 9988
Material Separation 5183 5204
Detachment of Device or Device Component 3850 3850
Adverse Event Without Identified Device or Use Problem 2654 3142
Material Integrity Problem 495 495
Material Frayed 359 359
Material Split, Cut or Torn 249 249
Patient-Device Incompatibility 227 227
Device Markings/Labelling Problem 214 214
Manufacturing, Packaging or Shipping Problem 209 331
Unraveled Material 198 198
Appropriate Term/Code Not Available 178 178
Component Missing 141 141
Patient Device Interaction Problem 117 117
Material Twisted/Bent 115 115
Product Quality Problem 107 107
Component Misassembled 99 99
Insufficient Information 95 95
Tear, Rip or Hole in Device Packaging 94 94
Positioning Failure 74 74
Dull, Blunt 73 73
Defective Component 72 72
Human-Device Interface Problem 71 71
Difficult to Open or Remove Packaging Material 64 64
Mechanical Problem 63 63
Delivered as Unsterile Product 61 61
Packaging Problem 57 57
Device Contaminated During Manufacture or Shipping 44 44
Use of Device Problem 44 44
Device Slipped 42 42
Device Appears to Trigger Rejection 40 40
Component or Accessory Incompatibility 33 33
Component Incompatible 21 21
Difficult to Remove 21 21
Material Deformation 20 20
Degraded 19 19
Material Fragmentation 18 18
Entrapment of Device 15 15
Positioning Problem 11 11
Nonstandard Device 11 11
Device Contamination with Chemical or Other Material 11 11
Fracture 11 11
Material Discolored 11 11
Inadequacy of Device Shape and/or Size 9 9
Defective Device 9 9
Separation Problem 9 9
Material Too Soft/Flexible 9 9
Biocompatibility 8 8
Loose or Intermittent Connection 8 130
Material Disintegration 7 7
Difficult to Open or Close 7 7
Contamination /Decontamination Problem 7 7
Device Fell 5 249
Migration 5 5
Failure to Fire 5 5
Device Misassembled During Manufacturing /Shipping 5 5
Material Protrusion/Extrusion 5 5
Separation Failure 5 5
Inaccurate Information 4 4
Mechanics Altered 4 4
Missing Information 4 4
Therapeutic or Diagnostic Output Failure 4 4
Sharp Edges 3 3
Disconnection 3 3
Material Too Rigid or Stiff 3 3
Unsealed Device Packaging 3 3
Leak/Splash 2 2
Physical Resistance/Sticking 2 2
Device Damaged Prior to Use 2 2
Fluid/Blood Leak 2 2
Structural Problem 2 2
Migration or Expulsion of Device 2 2
Expiration Date Error 1 1
Extra Components 1 1
Failure to Advance 1 1
Compatibility Problem 1 1
Corroded 1 1
Improper or Incorrect Procedure or Method 1 1
Deformation Due to Compressive Stress 1 1
Material Puncture/Hole 1 1
Loss of or Failure to Bond 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1
No Apparent Adverse Event 1 1
Misfire 1 1
Difficult or Delayed Positioning 1 1
Labelling, Instructions for Use or Training Problem 1 1
Noise, Audible 1 1
Stretched 1 1
Collapse 1 1
Material Rupture 1 1
Material Erosion 1 1
Unexpected Color 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Mechanical Jam 1 1
Incomplete or Missing Packaging 1 1
Expulsion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11762 12006
No Consequences Or Impact To Patient 4329 5444
Insufficient Information 1149 1149
Wound Dehiscence 1141 1141
Unspecified Infection 691 813
No Code Available 501 501
Inflammation 461 461
No Known Impact Or Consequence To Patient 461 461
Not Applicable 429 429
Pain 414 536
Post Operative Wound Infection 386 508
Foreign Body In Patient 360 482
Impaired Healing 299 421
Unspecified Tissue Injury 286 286
Hemorrhage/Bleeding 286 530
Unintended Radiation Exposure 245 245
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 230 230
No Patient Involvement 222 222
Abscess 183 183
Hematoma 170 170
Erythema 165 165
No Information 162 162
Fluid Discharge 156 156
Swelling/ Edema 129 129
Seroma 128 128
Failure to Anastomose 123 367
Pocket Erosion 119 119
Necrosis 112 112
Purulent Discharge 112 112
Granuloma 98 98
Hernia 97 97
Blood Loss 84 84
Radiation Exposure, Unintended 84 84
Scar Tissue 83 83
Foreign Body Reaction 83 83
Fistula 80 80
Fever 79 79
Hypersensitivity/Allergic reaction 79 79
Skin Inflammation/ Irritation 78 78
Device Embedded In Tissue or Plaque 78 78
Obstruction/Occlusion 77 77
Discomfort 62 62
Swelling 59 59
Cellulitis 53 53
Urinary Tract Infection 51 51
Local Reaction 49 49
Incontinence 47 47
Tissue Damage 41 41
Itching Sensation 36 36
Sepsis 35 35
Patient Problem/Medical Problem 33 33
Bacterial Infection 32 32
Eye Injury 30 30
Urinary Retention 29 29
Abdominal Pain 28 28
Erosion 23 23
Adhesion(s) 21 21
Laceration(s) 21 21
Ulcer 18 18
Peritonitis 18 18
Skin Erosion 18 18
Injury 18 18
Rash 18 18
Tissue Breakdown 17 17
Organ Dehiscence 17 17
Abnormal Vaginal Discharge 16 16
Stenosis 16 16
Eye Infections 15 15
Blister 15 15
Edema 15 15
Scarring 13 13
Vomiting 13 13
Skin Irritation 13 13
Skin Infection 13 13
Reaction 12 12
Anxiety 11 11
Chills 11 11
Visual Impairment 10 10
Perforation 10 10
Hematuria 9 9
Nausea 9 9
Bowel Perforation 9 9
Anemia 9 9
Cyst(s) 8 8
Visual Disturbances 8 8
Ptosis 8 8
Cerebrospinal Fluid Leakage 7 7
Nerve Damage 7 7
Headache 7 7
Shock 7 7
Fatigue 7 7
Muscle/Tendon Damage 7 7
Burning Sensation 7 7
Eye Pain 6 6
Antibiotics, Reaction To 6 6
Fibrosis 6 6
Failure of Implant 6 6
Thrombosis 6 6
Multiple Organ Failure 6 6
Diarrhea 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 Oct-31-2022
5 Ethicon, Inc. II May-10-2022
6 Ethicon, Inc. II Oct-16-2020
7 Ethicon, Inc. II Feb-04-2020
8 Ethicon, Inc. II Apr-12-2019
9 Gordian Surgical II Nov-03-2020
10 Riverpoint Medical, LLC II Feb-03-2021
11 Riverpoint Medical, LLC II Oct-01-2020
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