Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 53 53
2019 76 76
2020 52 52
2021 39 39
2022 70 70
2023 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Break 146 146
Material Separation 114 114
Detachment of Device or Device Component 60 60
Adverse Event Without Identified Device or Use Problem 22 22
Material Twisted/Bent 12 12
Dull, Blunt 6 6
Defective Component 6 6
Unraveled Material 4 4
Product Quality Problem 4 4
Appropriate Term/Code Not Available 3 3
Detachment Of Device Component 3 3
Delivered as Unsterile Product 3 3
Material Frayed 2 2
Use of Device Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Unclear Information 2 2
Noise, Audible 1 1
Migration 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Component Missing 1 1
Loose or Intermittent Connection 1 1
Difficult To Position 1 1
Corroded 1 1
Difficult or Delayed Positioning 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 157 157
No Consequences Or Impact To Patient 107 107
Not Applicable 27 27
No Known Impact Or Consequence To Patient 19 19
Wound Dehiscence 12 12
No Code Available 12 12
Insufficient Information 12 12
Foreign Body In Patient 9 9
Unspecified Infection 8 8
Pain 8 8
Hemorrhage/Bleeding 6 6
Inflammation 5 5
Tissue Damage 5 5
Post Operative Wound Infection 4 4
Blood Loss 4 4
Local Reaction 4 4
Granuloma 3 3
Toxicity 3 3
Hemostasis 3 3
Chest Pain 3 3
Foreign Body Reaction 3 3
Bone Fracture(s) 2 2
Erythema 2 2
Fever 2 2
Radiation Exposure, Unintended 2 2
Skin Irritation 2 2
Itching Sensation 2 2
Unspecified Tissue Injury 2 2
No Information 2 2
Pericardial Effusion 1 1
Muscle/Tendon Damage 1 1
Swelling/ Edema 1 1
Myocardial Infarction 1 1
Scar Tissue 1 1
Sepsis 1 1
Rupture 1 1
Device Embedded In Tissue or Plaque 1 1
No Patient Involvement 1 1
Respiratory Failure 1 1
Dyspnea 1 1
Adhesion(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Ischemia 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Pneumothorax 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
-
-