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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, patient transfer, powered
Regulation Description Powered patient transfer device.
Product CodeFRZ
Regulation Number 880.6775
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 3
2023 4 4
2024 2 2
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Device Slipped 1 1
Device-Device Incompatibility 1 1
Physical Resistance/Sticking 1 1
Contamination 1 1
Scratched Material 1 1
Product Quality Problem 1 1
Unintended System Motion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Fall 3 3
Unspecified Tissue Injury 2 2
Superficial (First Degree) Burn 1 1
Burn(s) 1 1
Insufficient Information 1 1
Loss of Range of Motion 1 1
Pain 1 1
Laceration(s) 1 1
Hemorrhage/Bleeding 1 1
Full thickness (Third Degree) Burn 1 1

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