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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
2017 3 3
2018 4 4
2020 8 8
2021 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Device Contamination with Chemical or Other Material 4 4
Detachment Of Device Component 3 3
Unsealed Device Packaging 3 3
Microbial Contamination of Device 2 2
Defective Device 2 2
Insufficient Information 2 2
Contamination 2 2
Contamination /Decontamination Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Appropriate Term/Code Not Available 1 1
Break 1 1
Device Emits Odor 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Hypersensitivity/Allergic reaction 4 4
Unspecified Infection 3 3
Laceration(s) 1 1
Reaction 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1
No Information 1 1
Irritation 1 1
Rash 1 1
No Consequences Or Impact To Patient 1 1
Insufficient Information 1 1

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