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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device collagen surgical mesh containing drugs
Definition Reinforcement of soft tissue where weakness exists.
Product CodePIJ
Regulation Number 878.3300
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 7 7
2021 6 6
2022 15 15
2023 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 26 26
Defective Device 25 25
Insufficient Information 4 4
Material Disintegration 3 3
Patient-Device Incompatibility 3 3
Material Separation 2 2
Biocompatibility 1 1
Material Split, Cut or Torn 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 20 20
Pain 19 19
Hernia 4 4
Injury 4 4
Seroma 3 3
Bowel Perforation 3 3
Fluid Discharge 2 2
Inflammation 2 2
Disability 2 2
Fistula 2 2
Purulent Discharge 2 2
Erythema 1 1
Wound Dehiscence 1 1
Adhesion(s) 1 1
Cellulitis 1 1
Failure of Implant 1 1
Local Reaction 1 1
Fasciitis 1 1
Reaction 1 1
Abdominal Distention 1 1
No Patient Involvement 1 1
Skin Discoloration 1 1
No Consequences Or Impact To Patient 1 1
Peritonitis 1 1
No Code Available 1 1
Swelling/ Edema 1 1

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