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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 2

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 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 310 310
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
Delivered as Unsterile Product 3 3
Microbial Contamination of Device 3 3
Device Markings/Labelling Problem 3 3
Device Contamination with Chemical or Other Material 2 2
Device Contaminated During Manufacture or Shipping 2 2
Tear, Rip or Hole in Device Packaging 2 2
Nonstandard Device 2 2
Failure To Adhere Or Bond 2 2
Therapeutic or Diagnostic Output Failure 2 2
Physical Resistance/Sticking 1 1
Extrusion 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Loss of or Failure to Bond 1 1
Detachment Of Device Component 1 1
Contamination 1 1
Positioning Failure 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Leak/Splash 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Reaction 1 1
Material Rupture 1 1
Obstruction of Flow 1 1
Malposition of Device 1 1
Incomplete or Missing Packaging 1 1
Device Issue 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Contamination /Decontamination Problem 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 111 111
Adhesion(s) 100 100
Fever 72 72
Inflammation 54 54
Obstruction/Occlusion 50 50
Peritonitis 48 48
Erosion 45 45
Not Applicable 41 41
Surgical procedure 26 26
Abdominal Pain 25 25
Hypersensitivity/Allergic reaction 16 16
Vomiting 15 15
Scar Tissue 14 14
Wound Dehiscence 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
Treatment with medication(s) 12 12
Fistula 12 12
Bacterial Infection 12 12
Blood Loss 11 11
Fluid Discharge 9 9
Edema 9 9
Incontinence 9 9
No Clinical Signs, Symptoms or Conditions 9 9
Insufficient Information 8 8
Purulent Discharge 8 8
Foreign Body Reaction 8 8
Discharge 8 8
Ascites 7 7
Reaction 7 7
Diarrhea 7 7
Hemorrhage/Bleeding 7 7
Nausea 6 6
Headache 6 6
Post Operative Wound Infection 6 6
Organ Dehiscence 6 6
Abdominal Distention 6 6
Foreign Body In Patient 5 5
Swelling 5 5
Erythema 5 5
Paralysis 5 5
Rash 5 5
Unspecified Tissue Injury 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Sepsis 4 4
Pneumonia 4 4
Seroma 4 4
Urinary Tract Infection 4 4
Stenosis 4 4
Neurological Deficit/Dysfunction 4 4
Discomfort 4 4
Urticaria 3 3
Hernia 3 3
Burning Sensation 3 3
Constipation 3 3
Hospitalization required 3 3
Ambulation Difficulties 3 3
Coma 3 3
Disability 3 3
Impaired Healing 3 3
Necrosis 3 3
Perforation 3 3
Scarring 3 3
Irritation 3 3
Fatigue 3 3
Emotional Changes 3 3
Granuloma 3 3
Cyst(s) 3 3
Failure to Anastomose 3 3
Swelling/ Edema 3 3
Cancer 2 2
Anaphylactic Shock 2 2
Death 2 2
Bleeding 2 2
Calcium Deposits/Calcification 2 2
Hematoma 2 2
Septic Shock 2 2
Numbness 2 2
Hematuria 2 2
Vascular System (Circulation), Impaired 2 2
Therapy/non-surgical treatment, additional 2 2
Alteration In Body Temperature 2 2
No Patient Involvement 2 2
Weakness 2 2
Abnormal Vaginal Discharge 2 2
Tissue Damage 2 2
Urinary Retention 2 2
Skin Irritation 2 2
Therapeutic Response, Decreased 2 2
Urinary Frequency 2 2
Physical Entrapment 1 1
Anxiety 1 1
Distress 1 1
Deformity/ Disfigurement 1 1
Tachycardia 1 1
Uterine Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Genzyme Corporation II Jun-21-2012
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