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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device brush, scrub, operating-room
Regulation Description Manual surgical instrument for general use.
Product CodeGEC
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 16 16
2022 1 1
2023 8 8
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination /Decontamination Problem 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Contamination 5 5
Unsealed Device Packaging 4 4
Device Contaminated During Manufacture or Shipping 2 2
Insufficient Information 2 2
Defective Device 2 2
Device Contamination with Chemical or Other Material 2 2
Disconnection 1 1
Microbial Contamination of Device 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Missing Information 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
Hypersensitivity/Allergic reaction 4 4
Insufficient Information 4 4
Unspecified Infection 3 3
No Known Impact Or Consequence To Patient 3 3
Rash 2 2
Irritation 1 1
No Patient Involvement 1 1
Laceration(s) 1 1
Reaction 1 1

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