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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ring (wound protector), drape retention, internal
Regulation Description Surgical drape and drape accessories.
Product CodeKGW
Regulation Number 878.4370
Device Class 2

MDR Year MDR Reports MDR Events
2017 58 58
2018 13 13
2019 11 11
2020 12 12
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Perforation 49 49
Material Split, Cut or Torn 15 15
Material Separation 6 6
Tear, Rip or Hole in Device Packaging 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Break 3 3
Detachment Of Device Component 3 3
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Device Dislodged or Dislocated 2 2
Use of Device Problem 2 2
Torn Material 1 1
Device Handling Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Fragmentation 1 1
Particulates 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 61 61
No Known Impact Or Consequence To Patient 21 21
No Patient Involvement 7 7
No Clinical Signs, Symptoms or Conditions 3 3
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Injury 1 1
Weight Changes 1 1
Abdominal Pain 1 1
Nerve Damage 1 1
Tissue Damage 1 1

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