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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)
2020 2021 2022 2023 2024 2025
7 8 7 4 9 5

MDR Year MDR Reports MDR Events
2020 44 44
2021 42 42
2022 53 53
2023 45 45
2024 38 38
2025 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 217 217
Delivered as Unsterile Product 7 7
Device Contaminated During Manufacture or Shipping 6 6
Improper or Incorrect Procedure or Method 5 5
Device Contamination with Chemical or Other Material 4 4
Difficult to Open or Remove Packaging Material 2 2
Appropriate Term/Code Not Available 2 2
Leak/Splash 1 1
Off-Label Use 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
Contamination /Decontamination Problem 1 1
Device Misassembled During Manufacturing /Shipping 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
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 60 60
Abscess 47 47
Adhesion(s) 40 40
Obstruction/Occlusion 36 36
Fever 35 35
Inflammation 25 25
Pain 24 24
No Clinical Signs, Symptoms or Conditions 20 20
Peritonitis 14 14
Abdominal Pain 13 13
Not Applicable 11 11
Insufficient Information 9 9
Fluid Discharge 9 9
Hypersensitivity/Allergic reaction 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Wound Dehiscence 7 7
Vomiting 6 6
No Code Available 6 6
Foreign Body In Patient 5 5
Unspecified Tissue Injury 5 5
Purulent Discharge 5 5
Injury 4 4
Hemorrhage/Bleeding 4 4
Bacterial Infection 4 4
Post Operative Wound Infection 4 4
Foreign Body Reaction 4 4
Hernia 3 3
Nausea 3 3
Headache 3 3
Swelling/ Edema 3 3
No Patient Involvement 2 2
Discomfort 2 2
Scar Tissue 2 2
Failure to Anastomose 2 2
Seroma 2 2
Blood Loss 2 2
Hematoma 2 2
Sepsis 2 2
No Consequences Or Impact To Patient 2 2
Emotional Changes 2 2
Impaired Healing 2 2
Urticaria 2 2
Fistula 2 2
Calcium Deposits/Calcification 1 1
Pulmonary Edema 1 1
Tachycardia 1 1
Stenosis 1 1
Deformity/ Disfigurement 1 1
Reaction 1 1
Pneumonia 1 1

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