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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apron, leaded
Product CodeEAJ
Regulation Number 892.6500
Device Class 1

MDR Year MDR Reports MDR Events
2019 10 10
2021 3 3
2022 1 1
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 9 9
Tear, Rip or Hole in Device Packaging 7 7
Product Quality Problem 6 6
Material Integrity Problem 3 3
Unintended Movement 1 1
Device Fell 1 1
Break 1 1
Corroded 1 1
Material Separation 1 1
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 5 5
Head Injury 1 1
No Consequences Or Impact To Patient 1 1
Radiation Exposure, Unintended 1 1
Muscle/Tendon Damage 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Burlington Medical, LLC II Jul-30-2019
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