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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
2021 5 5
2022 59 59
2023 7 7
2024 12 12
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 26 26
Degraded 19 19
Appropriate Term/Code Not Available 16 16
Lack of Effect 10 10
Patient Device Interaction Problem 6 6
Material Integrity Problem 4 4
Expiration Date Error 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Device Dislodged or Dislocated 2 2
Packaging Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 32 32
No Clinical Signs, Symptoms or Conditions 12 12
Sepsis 10 10
Bacterial Infection 8 8
Unspecified Infection 7 7
Hematoma 4 4
Impaired Healing 3 3
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Necrosis 2 2
Seroma 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Wound Dehiscence 1 1
Failure of Implant 1 1
Fungal Infection 1 1
Cyst(s) 1 1
Cellulitis 1 1
Skin Discoloration 1 1
Post Operative Wound Infection 1 1
Erythema 1 1
Pain 1 1
Scar Tissue 1 1
Abscess 1 1
Eye Injury 1 1
Swelling/ Edema 1 1
Hemorrhage/Bleeding 1 1
Full thickness (Third Degree) Burn 1 1
Fistula 1 1

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