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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
2017 2 2
2018 10 10
2019 4 4
2020 7 7
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 3 3
Premature Separation 3 3
Break 3 3
Material Split, Cut or Torn 2 2
Activation, Positioning or SeparationProblem 2 2
Device Markings/Labelling Problem 2 2
Decrease in Pressure 2 2
Device Contamination with Chemical or Other Material 1 1
Missing Information 1 1
Device Handling Problem 1 1
Unclear Information 1 1
Positioning Failure 1 1
Material Too Rigid or Stiff 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Torn Material 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 9 9
No Known Impact Or Consequence To Patient 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Reaction 4 4
Blood Loss 3 3
Tissue Breakdown 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Skin 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
2 The Seaberg Company Inc II Jun-14-2018
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