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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device protector, hearing (insert)
Product CodeEWD
Device Class Unclassified

MDR Year MDR Reports MDR Events
2019 2 2
2021 2 2
2022 1 1
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Break 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Patient Problem/Medical Problem 2 2
Device Embedded In Tissue or Plaque 1 1
Balance Problems 1 1
Partial Hearing Loss 1 1
Blister 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Infection 1 1
Peeling 1 1
Tinnitus 1 1
Complaint, Ill-Defined 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Cognitive Changes 1 1

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