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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, cast removal, ac-powered
Regulation Description Cast removal instrument.
Product CodeLGH
Regulation Number 888.5960
Device Class 1

MDR Year MDR Reports MDR Events
2024 2 2
2025 5 5
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 2 2
Temperature Problem 2 2
Mechanical Problem 1 1
Patient Device Interaction Problem 1 1
Failure to Cut 1 1
Overheating of Device 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Skin Tears 2 2
Superficial (First Degree) Burn 1 1
Abrasion 1 1
Alteration in Body Temperature 1 1
Erythema 1 1

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