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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clip, scalp
Product CodeHBO
Regulation Number 882.4150
Device Class 2

MDR Year MDR Reports MDR Events
2019 12 12
2020 2 2
2021 5 5
2022 3 3
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Compatibility Problem 11 11
Break 4 4
Material Fragmentation 3 3
Contamination /Decontamination Problem 2 2
Difficult to Open or Remove Packaging Material 1 1
Mechanical Problem 1 1
Peeled/Delaminated 1 1
Contamination 1 1
Material Discolored 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Failure to Eject 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
No Clinical Signs, Symptoms or Conditions 8 8
Foreign Body In Patient 4 4
Unspecified Infection 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Aug-06-2021
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