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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
Product CodeGEC
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 4 4
2020 8 8
2021 16 16
2022 1 1
2023 8 8

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 4 4
Device Contamination with Chemical or Other Material 4 4
Unsealed Device Packaging 4 4
Detachment Of Device Component 3 3
Device Contaminated During Manufacture or Shipping 2 2
Defective Device 2 2
Insufficient Information 2 2
Microbial Contamination of Device 2 2
Packaging Problem 1 1
Break 1 1
Disconnection 1 1
Device Emits Odor 1 1
Tear, Rip or Hole in Device Packaging 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 15 15
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 4 4
Hypersensitivity/Allergic reaction 4 4
Unspecified Infection 3 3
Rash 2 2
No Consequences Or Impact To Patient 1 1
Reaction 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1
Irritation 1 1
Laceration(s) 1 1
No Information 1 1

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