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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, deployer
Regulation Description Surgical mesh.
Definition Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).
Product CodeORQ
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 2 3
2023 1 1
2025 11 11
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 17
Break 2 2
Migration or Expulsion of Device 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 7 7
Muscle/Tendon Damage 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Inflammation 3 4
Loss of Range of Motion 3 3
Unspecified Infection 2 2
Foreign Body In Patient 2 2
Abscess 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body Reaction 1 1
Post Operative Wound Infection 1 1
Muscular Rigidity 1 1
Hernia 1 1
Fluid Discharge 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Erosion 1 1
Ascites 1 1

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