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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
PETERS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
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 4783 4783

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10192 11530
Material Separation 6374 6395
Detachment of Device or Device Component 4479 4479
Adverse Event Without Identified Device or Use Problem 3269 3757
Material Integrity Problem 542 542
Material Frayed 449 449
Patient-Device Incompatibility 273 273
Material Split, Cut or Torn 266 266
Unraveled Material 264 264
Manufacturing, Packaging or Shipping Problem 231 353
Device Markings/Labelling Problem 222 222
Appropriate Term/Code Not Available 202 202
Component Missing 173 173
Insufficient Information 158 158
Defective Component 133 133
Patient Device Interaction Problem 131 131
Material Twisted/Bent 123 123
Product Quality Problem 115 115
Component Misassembled 112 112
Positioning Failure 101 101
Tear, Rip or Hole in Device Packaging 95 95
Difficult to Open or Remove Packaging Material 82 82
Dull, Blunt 81 81
Delivered as Unsterile Product 80 80
Mechanical Problem 74 74
Human-Device Interface Problem 71 71
Packaging Problem 60 60
Device Contaminated During Manufacture or Shipping 60 60
Device Appears to Trigger Rejection 50 50
Use of Device Problem 49 49
Device Slipped 43 43
Component or Accessory Incompatibility 36 36
Material Deformation 23 23
Difficult to Remove 22 22
Material Discolored 21 21
Component Incompatible 21 21
Degraded 19 19
Material Fragmentation 18 18
Entrapment of Device 15 15
Separation Problem 15 15
Device Contamination with Chemical or Other Material 12 12
Positioning Problem 11 11
Fracture 11 11
Nonstandard Device 11 11
Defective Device 9 9
Material Too Soft/Flexible 9 9
Inadequacy of Device Shape and/or Size 9 9
Difficult to Open or Close 8 8
Loose or Intermittent Connection 8 130
Biocompatibility 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14966 15210
No Consequences Or Impact To Patient 4329 5444
Insufficient Information 1612 1612
Wound Dehiscence 1372 1372
Unspecified Infection 869 991
Inflammation 563 563
No Code Available 501 501
Pain 493 615
No Known Impact Or Consequence To Patient 461 461
Post Operative Wound Infection 430 552
Foreign Body In Patient 430 552
Not Applicable 429 429
Hemorrhage/Bleeding 362 606
Impaired Healing 356 478
Unspecified Tissue Injury 354 354
Unintended Radiation Exposure 291 291
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 237 237
No Patient Involvement 222 222
Hematoma 209 209
Abscess 202 202
Erythema 190 190
Fluid Discharge 184 184
Swelling/ Edema 174 174
No Information 162 162
Seroma 156 156
Pocket Erosion 146 146
Failure to Anastomose 146 390
Hernia 138 138
Purulent Discharge 137 137
Necrosis 131 131
Granuloma 130 130
Scar Tissue 114 114
Foreign Body Reaction 111 111
Fistula 106 106
Obstruction/Occlusion 99 99
Hypersensitivity/Allergic reaction 97 97
Skin Inflammation/ Irritation 95 95
Fever 92 92
Blood Loss 84 84
Radiation Exposure, Unintended 84 84
Device Embedded In Tissue or Plaque 80 80
Discomfort 70 70
Local Reaction 69 69
Urinary Tract Infection 66 66
Cellulitis 64 64
Swelling 59 59
Incontinence 56 56
Sepsis 43 43
Itching Sensation 42 42
Tissue Damage 41 41

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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