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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pill crusher/cutter
Definition A device used to cut or crush medication to aid in consumption. The device is intended to only be used with medications that are labeled as acceptable for crushing or cutting.
Product CodeOHY
Regulation Number 880.6430
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 2 2
2022 7 7
2023 3 3
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Use of Device Problem 3 3
Crack 1 1
Insufficient Information 1 1
Unsealed Device Packaging 1 1
Contamination /Decontamination Problem 1 1
Degraded 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Laceration(s) 5 5
Not Applicable 1 1
No Code Available 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Jun-24-2022
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