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 barrier, absorbable, adhesion
Product CodeMCN
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
7 7 8 7 4 5

MDR Year MDR Reports MDR Events
2019 55 55
2020 44 44
2021 42 42
2022 53 53
2023 45 45
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 218 218
Patient-Device Incompatibility 7 7
Improper or Incorrect Procedure or Method 3 3
Delivered as Unsterile Product 3 3
Unexpected Therapeutic Results 3 3
Tear, Rip or Hole in Device Packaging 2 2
Device Contaminated During Manufacture or Shipping 2 2
Appropriate Term/Code Not Available 2 2
Physical Resistance/Sticking 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Device 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Contamination with Chemical or Other Material 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
Leak/Splash 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 60 60
Abscess 46 46
Adhesion(s) 46 46
Obstruction/Occlusion 37 37
Pain 30 30
Fever 30 30
Inflammation 27 27
Not Applicable 20 20
No Code Available 19 19
Peritonitis 16 16
Abdominal Pain 14 14
Hypersensitivity/Allergic reaction 9 9
No Clinical Signs, Symptoms or Conditions 9 9
Insufficient Information 8 8
Fluid Discharge 8 8
Injury 8 8
Vomiting 7 7
Bacterial Infection 7 7
Purulent Discharge 7 7
Wound Dehiscence 6 6
Hemorrhage/Bleeding 6 6
Foreign Body Reaction 5 5
Post Operative Wound Infection 5 5
Unspecified Tissue Injury 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Consequences Or Impact To Patient 4 4
Rash 4 4
Edema 4 4
Emotional Changes 3 3
Erythema 3 3
Headache 3 3
Fistula 3 3
Nausea 3 3
Foreign Body In Patient 3 3
Blood Loss 3 3
Swelling/ Edema 3 3
Discomfort 2 2
Abdominal Distention 2 2
No Patient Involvement 2 2
Vascular System (Circulation), Impaired 2 2
Urticaria 2 2
Impaired Healing 2 2
Reaction 2 2
Pneumonia 2 2
Seroma 2 2
Scar Tissue 2 2
Sepsis 2 2
Death 2 2
Hematoma 2 2
Failure to Anastomose 2 2
Abortion 1 1
Anaphylactic Shock 1 1
Aspiration/Inhalation 1 1
Fatigue 1 1
Asphyxia 1 1
Calcium Deposits/Calcification 1 1
Cardiopulmonary Arrest 1 1
Cyst(s) 1 1
Hearing Loss 1 1
Diarrhea 1 1
Necrosis 1 1
Failure of Implant 1 1
Irritation 1 1
Itching Sensation 1 1
Menstrual Irregularities 1 1
Miscarriage 1 1
Septic Shock 1 1
Cramp(s) 1 1
Dizziness 1 1
Hernia 1 1
Stenosis 1 1
Therapeutic Response, Decreased 1 1
Skin Irritation 1 1
Tachycardia 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Uterine Perforation 1 1
Vertigo 1 1
Pulmonary Edema 1 1
Local Reaction 1 1
Numbness 1 1
Coma 1 1
Meningitis 1 1
Anxiety 1 1
Distress 1 1
Deformity/ Disfigurement 1 1
Ascites 1 1
Patient Problem/Medical Problem 1 1
Decreased Appetite 1 1
Cancer 1 1
Syncope/Fainting 1 1
Spontaneous Abortion 1 1
Drug Resistant Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-25-2024
-
-