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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
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 26 26
Appropriate Term/Code Not Available 19 19
Degraded 19 19
Adverse Event Without Identified Device or Use Problem 17 17
Material Integrity Problem 8 8
Expiration Date Error 4 4
Patient Device Interaction Problem 4 4
Break 3 3
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Markings/Labelling Problem 1 1
Failure of Device to Self-Test 1 1
Material Deformation 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 28 28
No Clinical Signs, Symptoms or Conditions 16 16
Unspecified Infection 13 13
Bacterial Infection 8 8
Injury 7 7
No Known Impact Or Consequence To Patient 7 7
Hematoma 4 4
Impaired Healing 3 3
Toxic Shock Syndrome 2 2
Necrosis 2 2
Pain 2 2
Cellulitis 2 2
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Post Operative Wound Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Swelling/ Edema 1 1
Full thickness (Third Degree) Burn 1 1
No Code Available 1 1
Cyst(s) 1 1
Erythema 1 1
Fistula 1 1
Hemorrhage/Bleeding 1 1
Failure of Implant 1 1
Wound Dehiscence 1 1
Abscess 1 1
Scar Tissue 1 1
Sepsis 1 1
Seroma 1 1
Skin Discoloration 1 1
No Consequences Or Impact To Patient 1 1
Fungal Infection 1 1

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