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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
dressing, wound and burn, hydrogel w/drug and/or biologic
Product Code
MGQ
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
FORWARD SCIENCE
SUBSTANTIALLY EQUIVALENT
1
GEL4MED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
2
2
2020
6
6
2021
1
1
2023
6
6
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
6
6
Patient-Device Incompatibility
2
2
Use of Device Problem
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
7
7
Death
3
3
Pain
2
2
Patient Problem/Medical Problem
2
2
No Code Available
1
1
Multiple Organ Failure
1
2
Skin Inflammation/ Irritation
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Swelling
1
1
Complaint, Ill-Defined
1
1
Impaired Healing
1
1
Tissue Breakdown
1
1
Erythema
1
1
Hemorrhage/Bleeding
1
1
Unspecified Infection
1
1
Necrosis
1
1
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