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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cover, barrier, protective
Product CodeMMP
Regulation Number 878.4370
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2021 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 2 2
Delivered as Unsterile Product 2 2
Structural Problem 1 1
Material Puncture/Hole 1 1
Component Missing 1 1
Contamination 1 1
Unsealed Device Packaging 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
2 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
3 Stryker Corporation II May-07-2020
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