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, absorbable
Product CodeGAK
Regulation Number 878.4830
Device Class 2

MDR Year MDR Reports MDR Events
2019 24 24
2020 22 22
2021 13 13
2022 20 20
2023 33 33
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 54 54
Break 50 50
Material Separation 13 13
Material Frayed 4 4
Appropriate Term/Code Not Available 3 3
Material Integrity Problem 3 3
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Improper Chemical Reaction 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Consequences Or Impact To Patient 23 23
Unspecified Infection 23 23
Insufficient Information 15 15
Pain 14 14
Wound Dehiscence 13 13
Hemorrhage/Bleeding 9 9
Not Applicable 8 8
Post Operative Wound Infection 7 7
Impaired Healing 7 7
No Code Available 6 6
Inflammation 6 6
Erythema 6 6
Abscess 5 5
Swelling/ Edema 5 5
Hematoma 5 5
Pocket Erosion 5 5
Scar Tissue 3 3
Failure to Anastomose 3 3
Urinary Retention 3 3
Foreign Body In Patient 3 3
Fever 3 3
Abdominal Distention 2 2
Perforation 2 2
Purulent Discharge 2 2
Blood Loss 2 2
Hypersensitivity/Allergic reaction 2 2
Fluid Discharge 2 2
Death 2 2
Unspecified Tissue Injury 1 1
Cellulitis 1 1
Swelling 1 1
Abrasion 1 1
Incontinence 1 1
Eye Injury 1 1
Sepsis 1 1
Deformity/ Disfigurement 1 1
Seroma 1 1
Anaphylactic Shock 1 1
Skin Inflammation/ Irritation 1 1
Obstruction/Occlusion 1 1
Bacterial Infection 1 1
Urinary Tract Infection 1 1
Necrosis 1 1
Fistula 1 1
Itching Sensation 1 1
Hernia 1 1

-
-