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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
Product CodeLGH
Regulation Number 888.5960
Device Class 1

MDR Year MDR Reports MDR Events
2018 8 8
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Fracture 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1
Device Operates Differently Than Expected 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
Abrasion 3 3
Burn(s) 1 1
Burn, Thermal 1 1
No Patient Involvement 1 1
No Code Available 1 1

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