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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device negative pressure wound therapy non-powered suction apparatus
Definition A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.
Product CodeOKO
Regulation Number 878.4683
Device Class 2


Premarket Reviews
ManufacturerDecision
BENQ MATERIALS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GUARD MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GUARD MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
SPIRACUR, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 2 2
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Premature Discharge of Battery 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Necrosis 2 2
Tissue Breakdown 2 2
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Injury 1 1
Bowel Perforation 1 1
Adhesion(s) 1 1

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