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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
CONEXTIONS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FOOSIN MEDICAL SUPPLIES INC., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 52 52
2021 39 39
2022 70 75
2023 100 100
2024 176 176
2025 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 221 226
Break 188 188
Detachment of Device or Device Component 60 60
Adverse Event Without Identified Device or Use Problem 26 26
Material Twisted/Bent 11 11
Device Contaminated During Manufacture or Shipping 7 7
Defective Component 7 7
Dull, Blunt 7 7
Delivered as Unsterile Product 5 5
Product Quality Problem 4 4
Unclear Information 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Use of Device Problem 2 2
Packaging Problem 2 2
Appropriate Term/Code Not Available 2 2
Disconnection 1 1
Material Frayed 1 1
Insufficient Information 1 1
Unraveled Material 1 1
Misfire 1 1
Component Missing 1 1
Migration 1 1
Corroded 1 1
Loose or Intermittent Connection 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 395 400
Insufficient Information 34 34
No Consequences Or Impact To Patient 32 32
Hemorrhage/Bleeding 24 24
Wound Dehiscence 9 9
Foreign Body In Patient 9 9
Tissue Breakdown 8 8
Bone Fracture(s) 6 6
Unspecified Infection 5 5
Not Applicable 5 5
Pain 5 5
Hypersensitivity/Allergic reaction 3 3
Inflammation 3 3
Local Reaction 3 3
Itching Sensation 2 2
Rupture 2 2
No Known Impact Or Consequence To Patient 2 2
Unspecified Tissue Injury 2 2
Tissue Damage 2 2
Unintended Radiation Exposure 2 2
Impaired Healing 1 1
Sepsis 1 1
No Code Available 1 1
Skin Irritation 1 1
No Information 1 1
Blood Loss 1 1
Osteopenia/ Osteoporosis 1 1
Cardiac Arrest 1 1
Post Operative Wound Infection 1 1
Rash 1 1
Needle Stick/Puncture 1 1
No Patient Involvement 1 1
Erythema 1 1
Hernia 1 1
Renal Impairment 1 1
Muscle/Tendon Damage 1 1
Pneumonia 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
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