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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device dressing, wound and burn, hydrogel w/drug and/or biologic
Product CodeMGQ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
FORWARD SCIENCE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 6 6
2021 1 1
2023 6 6
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Patient-Device Incompatibility 2 2
Insufficient Information 1 1
Use of Device Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 15 15
Death 3 3
Patient Problem/Medical Problem 2 2
Pain 2 2
Unspecified Infection 1 1
Impaired Healing 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Complaint, Ill-Defined 1 1
No Code Available 1 1
Necrosis 1 1
Skin Inflammation/ Irritation 1 1
Multiple Organ Failure 1 2
Erythema 1 1
Swelling 1 1
Hemorrhage/Bleeding 1 1
Cancer 1 1
Tissue Breakdown 1 1

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