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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, nonabsorbable, steel, monofilament and multifilament, sterile
Regulation Description Stainless steel suture.
Product CodeGAQ
Regulation Number 878.4495
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOOSIN MEDICAL SUPPLIES INC., LTD.
  SUBSTANTIALLY EQUIVALENT 1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 11 11
2018 53 53
2019 76 76
2020 52 52
2021 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Break 107 107
Material Separation 52 52
Detachment of Device or Device Component 50 50
Adverse Event Without Identified Device or Use Problem 18 18
Material Twisted/Bent 9 9
Dull, Blunt 5 5
Unraveled Material 4 4
Incorrect Device Or Component Shipped 3 3
Detachment Of Device Component 3 3
Appropriate Term/Code Not Available 3 3
Unclear Information 2 2
Difficult or Delayed Positioning 1 1
Material Frayed 1 1
Difficult To Position 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 110 110
No Clinical Signs, Symptoms or Conditions 40 40
Not Applicable 30 30
No Known Impact Or Consequence To Patient 24 24
No Code Available 12 12
Wound Dehiscence 11 11
Unspecified Infection 8 8
Pain 8 8
Foreign Body In Patient 7 7
Tissue Damage 5 5
Inflammation 5 5
Local Reaction 4 4
Blood Loss 4 4
Post Operative Wound Infection 4 4
Insufficient Information 4 4
Toxicity 3 3
Hemostasis 3 3
Chest Pain 3 3
Fever 3 3
Foreign Body Reaction 3 3
Granuloma 3 3
Hypersensitivity/Allergic reaction 2 2
Erythema 2 2
Hemorrhage/Bleeding 2 2
Itching Sensation 2 2
Skin Irritation 2 2
Radiation Exposure, Unintended 2 2
No Information 2 2
Device Embedded In Tissue or Plaque 1 1
Pericardial Effusion 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
No Patient Involvement 1 1
Respiratory Failure 1 1
Scar Tissue 1 1
Sepsis 1 1
Weakness 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Pneumothorax 1 1
Rash 1 1
Myocardial Infarction 1 1
Ischemia 1 1
Headache 1 1
Bone Fracture(s) 1 1
Dyspnea 1 1
Adhesion(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon, Inc. II Jun-19-2019
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