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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device barrier, absorbable, adhesion
Product CodeMCN
Device Class 3

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

MDR Year MDR Reports MDR Events
2019 55 55
2020 44 44
2021 42 42
2022 53 53
2023 45 45
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 219 219
Patient-Device Incompatibility 7 7
Device Contaminated During Manufacture or Shipping 3 3
Delivered as Unsterile Product 3 3
Unexpected Therapeutic Results 3 3
Improper or Incorrect Procedure or Method 3 3
Tear, Rip or Hole in Device Packaging 2 2
Appropriate Term/Code Not Available 2 2
Leak/Splash 1 1
Malposition of Device 1 1
Physical Resistance/Sticking 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination /Decontamination Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Positioning Failure 1 1
Use of Device Problem 1 1
Material Rupture 1 1
Material Deformation 1 1
Packaging Problem 1 1
Product Quality Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Nonstandard Device 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 60 60
Adhesion(s) 46 46
Abscess 46 46
Obstruction/Occlusion 38 38
Fever 30 30
Pain 30 30
Inflammation 27 27
Not Applicable 20 20
No Code Available 19 19
Peritonitis 16 16
Abdominal Pain 14 14
No Clinical Signs, Symptoms or Conditions 10 10
Hypersensitivity/Allergic reaction 9 9
Injury 8 8
Insufficient Information 8 8
Fluid Discharge 8 8
Bacterial Infection 7 7
Purulent Discharge 7 7
Vomiting 7 7
Wound Dehiscence 6 6
Hemorrhage/Bleeding 6 6
Unspecified Tissue Injury 5 5
Foreign Body Reaction 5 5
Post Operative Wound Infection 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Edema 4 4
No Consequences Or Impact To Patient 4 4
Rash 4 4
Nausea 3 3
Emotional Changes 3 3
Erythema 3 3
Swelling/ Edema 3 3
Foreign Body In Patient 3 3
Headache 3 3
Blood Loss 3 3
Fistula 3 3
Failure to Anastomose 2 2
Scar Tissue 2 2
Pneumonia 2 2
Reaction 2 2
Vascular System (Circulation), Impaired 2 2
No Patient Involvement 2 2
Discomfort 2 2
Seroma 2 2
Abdominal Distention 2 2
Hematoma 2 2
Urticaria 2 2
Impaired Healing 2 2
Death 2 2
Sepsis 2 2

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