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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, needle, diagnostic electromyograph
Product CodeIKT
Regulation Number 890.1385
Device Class 2

MDR Year MDR Reports MDR Events
2019 15 15
2020 3 3
2021 5 5
2022 4 4
2023 8 8
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 16 16
Break 6 6
Material Twisted/Bent 5 5
Detachment of Device or Device Component 3 3
Entrapment of Device 3 3
Separation Failure 2 2
Dull, Blunt 2 2
Defective Device 1 1
Device Slipped 1 1
Signal Artifact/Noise 1 1
Difficult to Remove 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Not Applicable 12 12
Foreign Body In Patient 7 7
Needle Stick/Puncture 5 5
Burn, Thermal 1 1
No Known Impact Or Consequence To Patient 1 1
Pain 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Technomed Europe II Sep-12-2022
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