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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light, surgical headlight
Product CodeEBA
Regulation Number 872.4630
Device Class 1

MDR Year MDR Reports MDR Events
2014 5 5
2015 4 4
2019 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Component Falling 2 2
Overheating of Device 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Smoking 1 1
Device Dislodged or Dislocated 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Appropriate Term/Code Not Available 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Device Maintenance Issue 1 1
Melted 1 1
Device Emits Odor 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5 5
No Information 2 2
No Code Available 1 1
No Known Impact Or Consequence To Patient 1 1
Burn(s) 1 1
Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kerr Corporation II Nov-20-2012
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