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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device component, traction, non-invasive
Product CodeKQZ
Regulation Number 888.5890
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 7 7
2021 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Positioning Failure 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Unstable 1 1
Mechanical Problem 1 1
Defective Device 1 1
Delivered as Unsterile Product 1 1
Packaging Problem 1 1
Electromagnetic Interference 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Pain 5 5
No Known Impact Or Consequence To Patient 3 3
Necrosis 1 1
Inflammation 1 1
Skin Inflammation 1 1
Insufficient Information 1 1
Laceration(s) 1 1
Skin Tears 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ossur Americas II Mar-11-2019
2 Smith & Nephew, Inc. II Feb-10-2022
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