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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device device, patient transfer, powered
Product CodeFRZ
Regulation Number 880.6775
Device Class 2

MDR Year MDR Reports MDR Events
2018 2 2
2019 2 2
2021 3 3
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 1 1
Protective Measures Problem 1 1
Excess Flow or Over-Infusion 1 1
Device Slipped 1 1
Product Quality Problem 1 1
Contamination 1 1
Infusion or Flow Problem 1 1
Unintended System Motion 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Deflation Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 5 5
No Known Impact Or Consequence To Patient 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Abrasion 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1
Loss of Range of Motion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Sustainability Solutions II Aug-11-2023
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