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TPLC
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Device
stocking, medical support (for general medical purposes)
Product Code
FQL
Regulation Number
880.5780
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
1
1
2016
1
1
2017
1
1
2018
1
1
2019
3
3
2022
3
3
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Improper or Incorrect Procedure or Method
3
3
Patient-Device Incompatibility
2
2
Device Operates Differently Than Expected
2
2
Insufficient Information
2
2
Data Problem
2
2
Material Deformation
1
1
Material Integrity Problem
1
1
Contamination
1
1
No Display/Image
1
1
Fire
1
1
Product Quality Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Complaint, Ill-Defined
3
3
Pain
3
3
No Known Impact Or Consequence To Patient
3
3
No Clinical Signs, Symptoms or Conditions
2
2
Swelling/ Edema
1
1
Swelling
1
1
Therapeutic Response, Decreased
1
1
Injury
1
1
Hip Fracture
1
1
Hypoesthesia, Foot/Leg
1
1
Bruise/Contusion
1
1
Burn(s)
1
1
Erythema
1
1
Fall
1
1
Hematoma
1
1
Unspecified Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Surgical Appliance Industries
II
Jan-11-2012
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