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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device suture, nonabsorbable, silk
Product CodeGAP
Regulation Number 878.5030
Device Class 2


Premarket Reviews
ManufacturerDecision
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SAFEPATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 55 55
2018 340 340
2019 333 333
2020 426 426
2021 437 437
2022 235 235

Device Problems MDRs with this Device Problem Events in those MDRs
Break 977 977
Adverse Event Without Identified Device or Use Problem 283 283
Material Separation 214 214
Detachment of Device or Device Component 103 103
Material Split, Cut or Torn 61 61
Detachment Of Device Component 32 32
Manufacturing, Packaging or Shipping Problem 31 31
Material Frayed 22 22
Material Integrity Problem 19 19
Biocompatibility 17 17
Delivered as Unsterile Product 16 16
Nonstandard Device 12 12
Inadequacy of Device Shape and/or Size 10 10
Component Incompatible 9 9
Insufficient Information 9 9
Component Misassembled 9 9
Device Markings/Labelling Problem 8 8
Appropriate Term/Code Not Available 8 8
Packaging Problem 8 8
Patient-Device Incompatibility 8 8
Product Quality Problem 8 8
Device Contaminated During Manufacture or Shipping 8 8
Defective Component 8 8
Material Twisted/Bent 6 6
Tear, Rip or Hole in Device Packaging 5 5
Material Discolored 4 4
Component Missing 4 4
Mechanical Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Migration 3 3
Device Operates Differently Than Expected 3 3
Device Issue 2 2
Material Fragmentation 2 2
Unsealed Device Packaging 2 2
Difficult to Remove 2 2
Incorrect Device Or Component Shipped 2 2
Contamination 2 2
Use of Device Problem 2 2
Entrapment of Device 2 2
Contamination /Decontamination Problem 2 2
Unraveled Material 2 2
Dull, Blunt 2 2
Loose or Intermittent Connection 1 1
Physical Property Issue 1 1
No Apparent Adverse Event 1 1
Device Slipped 1 1
Defective Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Poor Quality Image 1 1
Failure To Adhere Or Bond 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Compatibility Problem 1 1
Material Too Rigid or Stiff 1 1
Out-Of-Box Failure 1 1
Migration or Expulsion of Device 1 1
Material Disintegration 1 1
Fracture 1 1
Bent 1 1
Patient Device Interaction Problem 1 1
Illegible Information 1 1
Device Operational Issue 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 701 701
No Clinical Signs, Symptoms or Conditions 587 587
Inflammation 129 129
Not Applicable 117 117
Erythema 105 105
No Known Impact Or Consequence To Patient 103 103
Unspecified Infection 77 77
Pain 65 65
No Code Available 43 43
Fluid Discharge 38 38
Hemorrhage/Bleeding 36 36
Wound Dehiscence 35 35
Post Operative Wound Infection 27 27
Skin Irritation 26 26
Swelling/ Edema 26 26
Insufficient Information 23 23
Blood Loss 22 22
Itching Sensation 19 19
Fistula 18 18
Impaired Healing 18 18
Purulent Discharge 16 16
Foreign Body In Patient 14 14
Foreign Body Reaction 14 14
Swelling 14 14
No Information 13 13
Hypersensitivity/Allergic reaction 12 12
Radiation Exposure, Unintended 10 10
Abscess 10 10
Hernia 7 7
No Patient Involvement 7 7
Failure to Anastomose 7 7
Necrosis 7 7
Death 6 6
Hematoma 6 6
Pocket Erosion 6 6
Scar Tissue 6 6
Sepsis 5 5
Device Embedded In Tissue or Plaque 4 4
Erosion 4 4
Unintended Radiation Exposure 3 3
Edema 3 3
Bacterial Infection 3 3
Unspecified Tissue Injury 3 3
Pneumothorax 3 3
Adhesion(s) 3 3
Fever 3 3
Eye Injury 2 2
Granuloma 2 2
Discomfort 2 2
Burning Sensation 2 2
Skin Inflammation/ Irritation 2 2
Obstruction/Occlusion 2 2
Peritonitis 2 2
Conjunctivitis 2 2
Cyst(s) 1 1
Paresis 1 1
Hypoesthesia 1 1
Thrombosis 1 1
Abnormal Vaginal Discharge 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Thrombosis/Thrombus 1 1
Breast Mass 1 1
Ptosis 1 1
Hypoxia 1 1
Nausea 1 1
Patient Problem/Medical Problem 1 1
Local Reaction 1 1
Seroma 1 1
Urinary Tract Infection 1 1
Meningitis 1 1
Stenosis 1 1
Injury 1 1
Incontinence 1 1
Laceration(s) 1 1
Capsular Contracture 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
Premature Labor 1 1
Cerebrospinal Fluid Leakage 1 1
Dysphagia/ Odynophagia 1 1
Ulcer 1 1
Deformity/ Disfigurement 1 1
Joint Dislocation 1 1
Numbness 1 1
Abdominal Distention 1 1
Cardiac Tamponade 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon, Inc. II Jul-02-2020
2 Ethicon, Inc. II Jan-16-2019
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