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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 70
2023 100 100
2024 176 176
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 196 196
Break 153 153
Detachment of Device or Device Component 52 52
Adverse Event Without Identified Device or Use Problem 22 22
Material Twisted/Bent 11 11
Defective Component 6 6
Dull, Blunt 5 5
Delivered as Unsterile Product 5 5
Product Quality Problem 4 4
Device Contaminated During Manufacture or Shipping 3 3
Appropriate Term/Code Not Available 2 2
Unclear Information 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Packaging Problem 2 2
Use of Device Problem 2 2
Corroded 1 1
Loose or Intermittent Connection 1 1
Migration 1 1
Component Missing 1 1
Material Frayed 1 1
Insufficient Information 1 1
Misfire 1 1
Noise, Audible 1 1
Disconnection 1 1
Unraveled Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 326 326
No Consequences Or Impact To Patient 32 32
Insufficient Information 29 29
Hemorrhage/Bleeding 23 23
Foreign Body In Patient 9 9
Tissue Breakdown 8 8
Wound Dehiscence 7 7
Bone Fracture(s) 6 6
Not Applicable 5 5
Pain 3 3
Local Reaction 3 3
Hypersensitivity/Allergic reaction 3 3
Unspecified Infection 3 3
Inflammation 3 3
Itching Sensation 2 2
Tissue Damage 2 2
Rupture 2 2
Unspecified Tissue Injury 2 2
Unintended Radiation Exposure 2 2
No Known Impact Or Consequence To Patient 2 2
Rash 1 1
Sepsis 1 1
Skin Irritation 1 1
Impaired Healing 1 1
Cardiac Arrest 1 1
Erythema 1 1
Muscle/Tendon Damage 1 1
Swelling/ Edema 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Osteopenia/ Osteoporosis 1 1
No Information 1 1
No Code Available 1 1
Renal Impairment 1 1

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