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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tourniquet, nonpneumatic
Product CodeGAX
Regulation Number 878.5900
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 7 7
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Separation 3 3
Material Split, Cut or Torn 2 2
Activation, Positioning or Separation Problem 2 2
Break 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Device Slipped 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Unclear Information 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Blood Loss 2 2
Tissue Breakdown 1 1
No Known Impact Or Consequence To Patient 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mar-Med Co II Feb-02-2021
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