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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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 201 201
Break 157 157
Detachment of Device or Device Component 53 53
Adverse Event Without Identified Device or Use Problem 22 22
Material Twisted/Bent 11 11
Defective Component 6 6
Delivered as Unsterile Product 5 5
Dull, Blunt 5 5
Product Quality Problem 4 4
Device Contaminated During Manufacture or Shipping 3 3
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 335 335
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
Unspecified Infection 3 3
Hypersensitivity/Allergic reaction 3 3
Inflammation 3 3
Local Reaction 3 3
Pain 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
Skin Irritation 1 1
No Code Available 1 1
No Information 1 1
Blood Loss 1 1
Osteopenia/ Osteoporosis 1 1
Cardiac Arrest 1 1
Rash 1 1
Needle Stick/Puncture 1 1
Erythema 1 1
No Patient Involvement 1 1
Renal Impairment 1 1
Muscle/Tendon Damage 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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