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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
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
2019 76 76
2020 52 52
2021 39 39
2022 70 70
2023 100 100
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 152 152
Break 145 145
Detachment of Device or Device Component 50 50
Adverse Event Without Identified Device or Use Problem 17 17
Material Twisted/Bent 12 12
Defective Component 6 6
Dull, Blunt 6 6
Unraveled Material 4 4
Delivered as Unsterile Product 4 4
Product Quality Problem 4 4
Use of Device Problem 2 2
Material Frayed 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Unclear Information 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 1 1
Migration 1 1
Packaging Problem 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Misfire 1 1
Component Missing 1 1
Loose or Intermittent Connection 1 1
Corroded 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 212 212
No Consequences Or Impact To Patient 81 81
Insufficient Information 18 18
Not Applicable 17 17
Hemorrhage/Bleeding 11 11
Foreign Body In Patient 9 9
No Known Impact Or Consequence To Patient 8 8
No Code Available 8 8
Wound Dehiscence 8 8
Unspecified Infection 7 7
Pain 6 6
Bone Fracture(s) 4 4
Tissue Damage 4 4
Tissue Breakdown 3 3
Toxicity 3 3
Hemostasis 3 3
Hypersensitivity/Allergic reaction 3 3
Local Reaction 3 3
Inflammation 3 3
Foreign Body Reaction 3 3
Itching Sensation 2 2
Granuloma 2 2
Blood Loss 2 2
Unspecified Tissue Injury 2 2
Unintended Radiation Exposure 2 2
No Information 2 2
Radiation Exposure, Unintended 1 1
Swelling/ Edema 1 1
Renal Impairment 1 1
Muscle/Tendon Damage 1 1
No Patient Involvement 1 1
Respiratory Failure 1 1
Rupture 1 1
Dyspnea 1 1
Erythema 1 1
Fever 1 1
Ischemia 1 1
Sepsis 1 1
Skin Irritation 1 1
Pneumonia 1 1
Rash 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon, Inc. II Jun-19-2019
2 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
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