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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stocking, medical support (for general medical purposes)
Product CodeFQL
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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