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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 4 4
2017 6 6
2018 2 2
2019 2 2
2020 6 6
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Patient-Device Incompatibility 5 5
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 1 1
Nonstandard Device 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 4 4
Erythema 4 4
Unspecified Infection 3 3
Rash 3 3
Necrosis 2 2
Pain 2 2
Swelling 2 2
Burning Sensation 2 2
Patient Problem/Medical Problem 2 2
No Known Impact Or Consequence To Patient 1 1
Partial thickness (Second Degree) Burn 1 1
No Information 1 1
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
Burn(s) 1 1
Ulcer 1 1
Complaint, Ill-Defined 1 1
Deformity/ Disfigurement 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Post Traumatic Wound Infection 1 1
Tissue Breakdown 1 1
Skin Irritation 1 1
Irritation 1 1
Itching Sensation 1 1
Gangrene 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Mar-27-2017
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