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TPLC
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show TPLC since
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Device
device, patient transfer, powered
Product Code
FRZ
Regulation Number
880.6775
Device Class
2
Premarket Reviews
Manufacturer
Decision
DIACOR, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
2
2
2016
2
2
2017
3
3
2018
2
2
2019
2
2
2021
3
3
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Slipped
4
4
Deflation Problem
3
3
Insufficient Information
2
2
Use of Device Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Physical Resistance/Sticking
1
1
Contamination
1
1
Device Operates Differently Than Expected
1
1
Protective Measures Problem
1
1
Infusion or Flow Problem
1
1
Excess Flow or Over-Infusion
1
1
Component Falling
1
1
Product Quality Problem
1
1
Unintended System Motion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
7
7
Death
3
3
No Known Impact Or Consequence To Patient
3
3
No Clinical Signs, Symptoms or Conditions
2
2
No Information
2
2
Bone Fracture(s)
2
2
Pain
2
2
High Blood Pressure/ Hypertension
1
1
Hip Fracture
1
1
Head Injury
1
1
Abrasion
1
1
Injury
1
1
Insufficient Information
1
1
Loss of Range of Motion
1
1
Hyperglycemia
1
1
Physical Entrapment
1
1
Unspecified Tissue Injury
1
1
No Consequences Or Impact To Patient
1
1
Loss of consciousness
1
1
Hemorrhage/Bleeding
1
1
Full thickness (Third Degree) Burn
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Sustainability Solutions
II
Aug-11-2023
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