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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
2014 1 1
2015 1 1
2016 1 1
2017 1 1
2018 1 1
2019 1 1
2020 2 2
2021 2 2
2022 7 7
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Device Operates Differently Than Expected 2 2
Use of Device Problem 2 2
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Collapse 1 1
Detachment Of Device Component 1 1
Crack 1 1
Degraded 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Laceration(s) 5 5
No Known Impact Or Consequence To Patient 5 5
Not Applicable 1 1
No Code Available 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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