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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, surgical, absorbable, polydioxanone
Regulation Description Absorbable polydioxanone surgical suture.
Product CodeNEW
Regulation Number 878.4840
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 2
FOOSIN MEDICAL SUPPLIES INC., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANS BIOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HYUNDAE MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PDO MAX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUTURION AB
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1010 1010
2021 1464 1830
2022 1537 2757
2023 1975 1975
2024 2118 2118
2025 1287 2286

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4777 5509
Material Separation 2155 2155
Adverse Event Without Identified Device or Use Problem 1382 2625
Positioning Failure 311 311
Material Integrity Problem 303 303
Detachment of Device or Device Component 134 378
Patient Device Interaction Problem 116 238
Defective Component 86 86
Material Frayed 84 84
Migration 71 71
Device Markings/Labelling Problem 53 53
Delivered as Unsterile Product 46 46
Component Misassembled 44 44
Material Twisted/Bent 39 161
Material Protrusion/Extrusion 34 156
Material Split, Cut or Torn 33 33
Separation Problem 31 31
Device Contaminated During Manufacture or Shipping 28 28
Positioning Problem 22 22
Appropriate Term/Code Not Available 20 20
Migration or Expulsion of Device 20 20
Manufacturing, Packaging or Shipping Problem 19 19
Difficult to Open or Remove Packaging Material 19 19
Tear, Rip or Hole in Device Packaging 15 15
Device Appears to Trigger Rejection 14 14
Expulsion 12 12
Component Missing 9 9
Product Quality Problem 8 8
Packaging Problem 8 8
Insufficient Information 7 7
Dull, Blunt 7 7
Device Fell 6 6
Material Fragmentation 6 6
Material Discolored 6 6
Material Deformation 6 6
Difficult or Delayed Positioning 5 5
Patient-Device Incompatibility 4 4
Separation Failure 4 4
Inadequacy of Device Shape and/or Size 4 4
Entrapment of Device 4 4
Use of Device Problem 4 4
Nonstandard Device 2 2
Loose or Intermittent Connection 2 2
Material Rupture 2 2
Degraded 2 2
Crack 2 2
Incomplete or Missing Packaging 2 2
Device Slipped 2 2
Difficult or Delayed Separation 1 1
Dent in Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6611 7099
Wound Dehiscence 710 1953
No Consequences Or Impact To Patient 678 678
Unspecified Infection 428 550
Insufficient Information 317 439
Pain 197 197
Hemorrhage/Bleeding 160 160
Hernia 125 125
Inflammation 111 111
Foreign Body In Patient 111 355
Failure to Anastomose 105 105
Hematoma 104 104
Post Operative Wound Infection 103 225
Abscess 101 101
Impaired Healing 95 217
Fistula 89 89
Pocket Erosion 85 85
Obstruction/Occlusion 81 81
Not Applicable 80 80
Fluid Discharge 78 200
Swelling/ Edema 75 75
Seroma 73 1072
Erythema 70 70
Unspecified Tissue Injury 68 68
Necrosis 67 1066
Discomfort 64 64
Purulent Discharge 57 57
Hypersensitivity/Allergic reaction 54 54
Skin Inflammation/ Irritation 53 53
Granuloma 45 45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 45 167
Nodule 42 42
Scar Tissue 35 35
Fever 34 34
Sepsis 33 33
No Code Available 29 29
Urinary Tract Infection 28 28
Foreign Body Reaction 28 28
Incontinence 25 25
Local Reaction 25 25
Itching Sensation 24 24
Joint Dislocation 21 21
Rupture 20 20
Ulcer 19 19
Cellulitis 18 18
Blood Loss 18 18
No Known Impact Or Consequence To Patient 17 17
Thrombosis/Thrombus 15 15
Adhesion(s) 13 13
Urinary Retention 13 13

Recalls
Manufacturer Recall Class Date Posted
1 ETHICON, LLC II Sep-30-2024
2 Ethicon Endo Surgery, LLC II Apr-03-2025
3 Ethicon, Inc. II Jun-14-2024
4 Ethicon, Inc. II May-10-2023
5 Ethicon, Inc. II Dec-14-2022
6 Ethicon, Inc. II Sep-20-2022
7 Ethicon, Inc. II Feb-06-2020
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