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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device absorbable synthetic wound dressing
Definition Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Product CodeQSZ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ACERA SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYNOVO BIOMATERIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 15 15
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 12 12
Adverse Event Without Identified Device or Use Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Use of Device Problem 2 2
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Impaired Healing 4 4
Pain 2 2
Insufficient Information 2 2
Failure of Implant 2 2
Unspecified Infection 1 1
Inflammation 1 1
Necrosis 1 1
Bacterial Infection 1 1
Purulent Discharge 1 1
Erythema 1 1
Hematoma 1 1
Fluid Discharge 1 1
Skin Disorders 1 1
Unspecified Tissue Injury 1 1

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