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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
2 5 8 4 3 1 2 7 5 1 7 7 8 7 4 7

MDR Year MDR Reports MDR Events
2014 53 53
2015 68 68
2016 71 71
2017 58 58
2018 65 65
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 314 314
Appropriate Term/Code Not Available 89 89
Other (for use when an appropriate device code cannot be identified) 29 29
Migration or Expulsion of Device 27 27
Insufficient Information 27 27
Material Erosion 17 17
Patient-Device Incompatibility 17 17
Defective Device 8 8
Device Operates Differently Than Expected 7 7
Improper or Incorrect Procedure or Method 6 6
Unsealed Device Packaging 5 5
Unexpected Therapeutic Results 4 4
Device Contaminated During Manufacture or Shipping 3 3
Device Markings/Labelling Problem 3 3
Delivered as Unsterile Product 3 3
Microbial Contamination of Device 3 3
Nonstandard Device 2 2
Device Contamination with Chemical or Other Material 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure To Adhere Or Bond 2 2
Therapeutic or Diagnostic Output Failure 2 2
Contamination 1 1
Contamination /Decontamination Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Positioning Failure 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Reaction 1 1
Material Rupture 1 1
Material Deformation 1 1
Packaging Problem 1 1
Product Quality Problem 1 1
Material Disintegration 1 1
Physical Property Issue 1 1
Physical Resistance/Sticking 1 1
Malposition of Device 1 1
Incomplete or Missing Packaging 1 1
Entrapment of Device 1 1
Extrusion 1 1
Leak/Splash 1 1
Device Issue 1 1
Loss of or Failure to Bond 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 135 135
Pain 129 129
Unspecified Infection 121 121
Abscess 112 112
Adhesion(s) 100 100
Fever 72 72
Inflammation 54 54
Obstruction/Occlusion 51 51
Peritonitis 48 48
Erosion 45 45
Not Applicable 41 41
Surgical procedure 26 26
Abdominal Pain 25 25
Hypersensitivity/Allergic reaction 16 16
Wound Dehiscence 15 15
Vomiting 15 15
Scar Tissue 14 14
No Consequences Or Impact To Patient 13 13
Other (for use when an appropriate patient code cannot be identified) 13 13
Injury 13 13
Fistula 12 12
Treatment with medication(s) 12 12
Bacterial Infection 12 12
Blood Loss 11 11
Fluid Discharge 10 10
No Clinical Signs, Symptoms or Conditions 10 10
Incontinence 9 9
Foreign Body Reaction 9 9
Edema 9 9
Insufficient Information 8 8
Purulent Discharge 8 8
Discharge 8 8
Reaction 7 7
Post Operative Wound Infection 7 7
Ascites 7 7
Hemorrhage/Bleeding 7 7
Diarrhea 7 7
Nausea 6 6
Abdominal Distention 6 6
Headache 6 6
Organ Dehiscence 6 6
Paralysis 5 5
Rash 5 5
Foreign Body In Patient 5 5
Erythema 5 5
Swelling 5 5
Unspecified Tissue Injury 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Discomfort 4 4
Impaired Healing 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-25-2024
2 Genzyme Corporation II Jun-21-2012
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