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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, dermal replacement
Product CodeMDD
Device Class 3

MDR Year MDR Reports MDR Events
2017 8 8
2018 10 10
2019 9 9
2020 19 19
2021 5 5
2022 62 62
2023 8 8
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 27 27
Adverse Event Without Identified Device or Use Problem 23 23
Appropriate Term/Code Not Available 22 22
Degraded 19 19
Material Integrity Problem 10 10
Device Operates Differently Than Expected 6 6
Expiration Date Error 4 4
Patient Device Interaction Problem 4 4
Break 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 1 1
Failure of Device to Self-Test 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1
Folded 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Device Expiration Issue 1 1
Product Quality Problem 1 1
Shelf Life Exceeded 1 1
Shipping Damage or Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 28 28
Unspecified Infection 19 19
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 14 14
Injury 8 8
Bacterial Infection 8 8
Hematoma 4 4
Impaired Healing 4 4
Seroma 3 3
No Consequences Or Impact To Patient 3 3
Toxic Shock Syndrome 2 2
Post Operative Wound Infection 2 2
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Necrosis 2 2
Pain 2 2
Wound Dehiscence 2 2
Cellulitis 2 2
Cyst(s) 1 1
Death 1 1
Erythema 1 1
Fistula 1 1
Abscess 1 1
Burn(s) 1 1
Local Reaction 1 1
Scar Tissue 1 1
Sepsis 1 1
Hemorrhage/Bleeding 1 1
Failure of Implant 1 1
Inflammation 1 1
Swelling/ Edema 1 1
Full thickness (Third Degree) Burn 1 1
No Code Available 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Ambulation Difficulties 1 1
Fungal Infection 1 1
Skin Discoloration 1 1

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