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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, drying
Product CodeJRJ
Regulation Number 862.2050
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2020 5 5
2021 1 1
2023 1 1
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 6 6
Insufficient Information 4 4
Break 2 2
Melted 2 2
Overheating of Device 2 2
Smoking 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
Protective Measures Problem 1 1
Device Emits Odor 1 1
Charred 1 1
Entrapment of Device 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Laceration(s) 5 5
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Abrasion 1 1
Insufficient Information 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cenorin, LLC II Aug-14-2017
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