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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
Regulation Description Absorbable poly(glycolide/l-lactide) surgical suture.
Product CodeGAM
Regulation Number 878.4493
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNACIONAL FARMACÉUTICA S.A DE C.V
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL INC .
  SUBSTANTIALLY EQUIVALENT 2
PETERS SURGICAL
  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
2020 3415 3429
2021 4506 4880
2022 4814 5550
2023 5070 5070
2024 7226 7226
2025 7464 7464

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12383 12639
Material Separation 8149 8149
Detachment of Device or Device Component 5792 5798
Adverse Event Without Identified Device or Use Problem 3836 4329
Material Integrity Problem 532 532
Material Frayed 472 472
Patient-Device Incompatibility 344 344
Material Split, Cut or Torn 308 308
Unraveled Material 300 300
Device Markings/Labelling Problem 261 261
Manufacturing, Packaging or Shipping Problem 250 372
Insufficient Information 249 249
Component Missing 218 218
Defective Component 208 209
Material Twisted/Bent 179 183
Device Contaminated During Manufacture or Shipping 167 167
Appropriate Term/Code Not Available 161 161
Positioning Failure 155 155
Component Misassembled 148 148
Patient Device Interaction Problem 137 137
Product Quality Problem 132 136
Delivered as Unsterile Product 107 107
Dull, Blunt 104 104
Difficult to Open or Remove Packaging Material 87 87
Mechanical Problem 80 80
Human-Device Interface Problem 67 67
Use of Device Problem 59 59
Device Appears to Trigger Rejection 56 56
Tear, Rip or Hole in Device Packaging 53 53
Packaging Problem 47 47
Device Slipped 44 44
Material Discolored 32 32
Component or Accessory Incompatibility 31 31
No Apparent Adverse Event 26 26
Difficult to Remove 25 25
Separation Problem 21 21
Material Deformation 17 17
Missing Information 14 14
Degraded 14 14
Entrapment of Device 14 14
Fracture 11 11
Difficult to Open or Close 11 11
Material Disintegration 10 10
Biocompatibility 10 10
Extra Components 9 9
Defective Device 7 7
Nonstandard Device 7 7
Device Contamination with Chemical or Other Material 7 7
Material Fragmentation 7 7
Structural Problem 7 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22707 22953
Insufficient Information 2483 2489
No Consequences Or Impact To Patient 2034 2037
Wound Dehiscence 1745 1745
Unspecified Infection 1008 1130
Inflammation 607 607
Pain 558 680
Foreign Body In Patient 533 656
Hemorrhage/Bleeding 522 766
Impaired Healing 469 591
Post Operative Wound Infection 440 562
Unspecified Tissue Injury 394 394
Unintended Radiation Exposure 362 362
Erythema 262 262
Swelling/ Edema 260 260
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 254 259
Fluid Discharge 250 250
Hematoma 234 234
No Code Available 234 234
Not Applicable 221 221
Failure to Anastomose 220 464
Abscess 215 215
Necrosis 213 213
Pocket Erosion 212 212
Seroma 191 191
Hernia 178 178
Purulent Discharge 168 168
Scar Tissue 163 163
Granuloma 156 156
Skin Inflammation/ Irritation 149 149
Obstruction/Occlusion 132 132
Fistula 131 131
No Patient Involvement 119 119
Foreign Body Reaction 117 117
Hypersensitivity/Allergic reaction 114 114
Discomfort 111 111
Local Reaction 110 110
Fever 103 103
Tissue Breakdown 99 99
No Known Impact Or Consequence To Patient 95 104
No Information 84 84
Urinary Tract Infection 68 68
Device Embedded In Tissue or Plaque 59 59
Cellulitis 59 59
Incontinence 59 59
Eye Injury 58 58
Itching Sensation 53 53
Blood Loss 49 49
Sepsis 48 48
Laceration(s) 47 47

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Feb-19-2020
2 Covidien, LP II Nov-11-2022
3 Ethicon, Inc. II Nov-07-2024
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 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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