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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
Product Quality Problem 4 4
Unraveled Material 4 4
Delivered as Unsterile Product 4 4
Material Frayed 2 2
Use of Device Problem 2 2
Appropriate Term/Code Not Available 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Unclear Information 2 2
Device Contaminated During Manufacture or Shipping 2 2
Loose or Intermittent Connection 1 1
Disconnection 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Packaging Problem 1 1
Component Missing 1 1
Misfire 1 1
Corroded 1 1
Migration 1 1
Material Integrity Problem 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 Code Available 8 8
No Known Impact Or Consequence To Patient 8 8
Wound Dehiscence 8 8
Unspecified Infection 7 7
Pain 6 6
Tissue Damage 4 4
Bone Fracture(s) 4 4
Foreign Body Reaction 3 3
Inflammation 3 3
Hemostasis 3 3
Tissue Breakdown 3 3
Toxicity 3 3
Local Reaction 3 3
Hypersensitivity/Allergic reaction 3 3
No Information 2 2
Granuloma 2 2
Blood Loss 2 2
Itching Sensation 2 2
Unintended Radiation Exposure 2 2
Unspecified Tissue Injury 2 2
Renal Impairment 1 1
No Patient Involvement 1 1
Radiation Exposure, Unintended 1 1
Muscle/Tendon Damage 1 1
Sepsis 1 1
Ischemia 1 1
Pneumonia 1 1
Rash 1 1
Fever 1 1
Rupture 1 1
Skin Irritation 1 1
Erythema 1 1
Swelling/ Edema 1 1
Dyspnea 1 1
Respiratory Failure 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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