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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
2020 19 19
2021 5 5
2022 62 62
2023 8 8
2024 14 14
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 27 27
Degraded 19 19
Appropriate Term/Code Not Available 17 17
Adverse Event Without Identified Device or Use Problem 12 12
Lack of Effect 10 10
Material Integrity Problem 7 7
Patient Device Interaction Problem 6 6
Break 5 5
Expiration Date Error 4 4
Device Dislodged or Dislocated 2 2
Device Markings/Labelling Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Material Deformation 1 1
Packaging Problem 1 1
Product Quality Problem 1 1
Failure of Device to Self-Test 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 18 18
Unspecified Infection 15 15
Sepsis 10 10
Bacterial Infection 8 8
Hematoma 5 5
No Known Impact Or Consequence To Patient 5 5
Impaired Healing 3 3
Skin Infection 2 2
Necrosis 2 2
Skin Inflammation/ Irritation 2 2
Seroma 2 2
Injury 2 2
Toxic Shock Syndrome 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
No Code Available 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
Swelling/ Edema 1 1
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1
Full thickness (Third Degree) Burn 1 1
Fistula 1 1

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