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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Product CodeKOJ
Regulation Number 872.6080
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Excess Flow or Over-Infusion 1 1
Improper or Incorrect Procedure or Method 1 1
Device Operates Differently Than Expected 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Swelling 2 2
Numbness 1 1
Chemical Exposure 1 1
Dyspnea 1 1
Hypersensitivity/Allergic reaction 1 1
Infiltration into Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Groman Inc. III Jan-13-2012
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