• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 2
CPT SUTURES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 2
FOOSIN MEDICAL SUPPLIES INC., LTD
  SUBSTANTIALLY EQUIVALENT 2
GORDIAN SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NANTONG HOLYCON MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL INC .
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
RESORBA MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
RK MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SAMYANG HOLDINGS CORP., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SILHOUETTE LIFT INC.
  SUBSTANTIALLY EQUIVALENT 1
SILHOUETTE LIFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
SM ENG CO., LTD
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 1498 1498
2018 2228 3465
2019 3564 4679
2020 3414 3414
2021 4509 4875
2022 3152 3152

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7186 9517
Detachment of Device or Device Component 3378 3378
Material Separation 3195 3216
Adverse Event Without Identified Device or Use Problem 2257 2501
Appropriate Term/Code Not Available 590 590
Material Integrity Problem 483 483
Detachment Of Device Component 296 296
Patient-Device Incompatibility 263 263
Unraveled Material 249 249
Material Frayed 224 224
Manufacturing, Packaging or Shipping Problem 190 190
Material Split, Cut or Torn 175 175
Device Markings/Labelling Problem 154 154
Insufficient Information 127 127
Component Missing 119 119
Tear, Rip or Hole in Device Packaging 107 107
Product Quality Problem 107 107
Failure To Adhere Or Bond 100 100
Material Twisted/Bent 91 91
Human-Device Interface Problem 85 85
Patient Device Interaction Problem 76 76
Component Misassembled 72 72
Loss of or Failure to Bond 68 68
Mechanical Problem 63 63
Device Operates Differently Than Expected 61 61
Dull, Blunt 60 60
Packaging Problem 54 54
Degraded 49 49
Component Incompatible 42 42
Device Misassembled During Manufacturing /Shipping 39 39
Device Appears to Trigger Rejection 37 37
Delivered as Unsterile Product 36 36
Material Fragmentation 33 33
Component or Accessory Incompatibility 31 31
Positioning Failure 30 30
Device Slipped 30 30
Loose or Intermittent Connection 29 29
Difficult to Open or Remove Packaging Material 29 29
Fracture 28 28
Use of Device Problem 27 27
Defective Component 27 27
Bent 26 26
Difficult to Remove 22 22
Device Contaminated During Manufacture or Shipping 21 21
No Apparent Adverse Event 20 20
Material Deformation 20 20
Extrusion 19 19
Entrapment of Device 19 19
Device Packaging Compromised 14 14
Positioning Problem 13 13
Material Protrusion/Extrusion 13 13
Material Disintegration 13 13
Nonstandard Device 11 11
Material Too Soft/Flexible 11 11
Device Contamination with Chemical or Other Material 11 11
Defective Device 11 11
Inadequacy of Device Shape and/or Size 10 10
Material Erosion 9 9
Device Fell 9 131
Separation Problem 9 9
Naturally Worn 9 9
Device Issue 8 8
Device Dislodged or Dislocated 8 8
Contamination /Decontamination Problem 7 7
Difficult to Open or Close 7 7
Migration or Expulsion of Device 7 7
Component Falling 7 7
Out-Of-Box Failure 7 7
Difficult To Position 6 6
Device Or Device Fragments Location Unknown 6 6
Failure to Fire 6 6
Malposition of Device 6 6
Biocompatibility 6 6
Mechanics Altered 6 6
Migration 6 6
Inaccurate Information 5 5
Compatibility Problem 5 5
Unsealed Device Packaging 5 5
Material Discolored 5 5
Leak/Splash 5 5
Device Damaged Prior to Use 4 4
Separation Failure 4 4
Physical Property Issue 4 4
Therapeutic or Diagnostic Output Failure 4 4
Split 3 3
Incorrect Device Or Component Shipped 3 3
Material Puncture/Hole 3 3
Structural Problem 3 3
Material Too Rigid or Stiff 3 3
Knotted 3 3
Fluid Leak 3 3
Disconnection 3 3
Difficult or Delayed Positioning 3 3
Cross Reactivity 3 3
Contamination 3 3
Misassembled 2 2
Material Rupture 2 2
Poor Quality Image 2 2
Obstruction of Flow 2 2
Expulsion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6171 6293
No Consequences Or Impact To Patient 4751 7103
No Known Impact Or Consequence To Patient 2211 2211
No Code Available 1030 1030
Wound Dehiscence 1028 1028
Not Applicable 816 816
Unspecified Infection 786 908
Insufficient Information 634 634
Pain 471 471
Post Operative Wound Infection 447 447
Inflammation 385 385
No Patient Involvement 305 305
Foreign Body In Patient 282 282
Impaired Healing 229 351
Abscess 212 212
Hemorrhage/Bleeding 194 316
Unspecified Tissue Injury 194 194
Hematoma 192 192
Radiation Exposure, Unintended 191 191
No Information 175 175
Blood Loss 173 173
Unintended Radiation Exposure 163 163
Seroma 159 159
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 151 151
Erythema 133 133
Swelling 129 129
Device Embedded In Tissue or Plaque 124 124
Hernia 113 113
Failure to Anastomose 109 109
Necrosis 106 106
Granuloma 104 104
Fistula 101 101
Fluid Discharge 97 97
Foreign Body Reaction 86 86
Purulent Discharge 85 85
Fever 82 82
Tissue Damage 82 82
Obstruction/Occlusion 80 80
Swelling/ Edema 74 74
Reaction 66 66
Injury 64 64
Hypersensitivity/Allergic reaction 64 64
Pocket Erosion 63 63
Urinary Tract Infection 62 62
Cellulitis 58 58
Scar Tissue 52 52
Incontinence 51 51
Patient Problem/Medical Problem 44 44
Discomfort 42 42
Organ Dehiscence 40 40
Local Reaction 40 40
Irritation 39 39
Sepsis 38 38
Urinary Retention 35 35
Itching Sensation 34 34
Skin Inflammation/ Irritation 33 33
Erosion 32 32
Bacterial Infection 28 28
Adhesion(s) 26 26
Edema 25 25
Eye Injury 25 25
Rash 25 25
Skin Irritation 24 24
Scarring 22 22
Abnormal Vaginal Discharge 21 21
Abdominal Pain 21 21
Peritonitis 16 16
Skin Erosion 15 15
Eye Infections 15 15
Hematuria 14 14
Stenosis 14 14
Blurred Vision 13 13
Thrombosis 13 13
Vomiting 13 13
Death 13 13
Failure of Implant 12 12
Ulcer 12 12
Laceration(s) 11 11
Visual Impairment 10 10
Perforation 10 10
Skin Inflammation 10 10
Skin Infection 9 9
Discharge 9 9
Cyst(s) 9 9
Cerebrospinal Fluid Leakage 9 9
Anemia 9 9
High Blood Pressure/ Hypertension 8 8
Nerve Damage 8 8
Ptosis 8 8
Bowel Perforation 7 7
Bruise/Contusion 7 7
Antibiotics, Reaction To 6 6
Dysphagia/ Odynophagia 6 6
Staphylococcus Aureus 6 6
Burning Sensation 6 6
Fibrosis 6 6
Blister 6 6
Abdominal Distention 5 5
Numbness 5 5
Visual Disturbances 5 5

Recalls
Manufacturer Recall Class Date Posted
1 CP Medical Inc II Dec-06-2019
2 CP Medical Inc II Apr-20-2017
3 Covidien LLC II Feb-19-2020
4 Covidien LLC II Aug-03-2018
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 Ethicon, Inc. II Feb-23-2018
10 Gordian Surgical II Nov-03-2020
11 Medtronic II Jun-14-2017
12 Riverpoint Medical, LLC II Feb-03-2021
13 Riverpoint Medical, LLC II Oct-01-2020
-
-