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TPLC
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Device
ultrasonic diathermy for use in applying therapeutic deep heat
Regulation Description
Ultrasonic diathermy.
Product Code
IMI
Regulation Number
890.5300
Device Class
2
Premarket Reviews
Manufacturer
Decision
CARCI INDUSTRIA E COMERCIO DE APARELHOS CIRURGICOS E ORTO
SUBSTANTIALLY EQUIVALENT
1
ENRAF-NONIUS, B.V.
SUBSTANTIALLY EQUIVALENT
1
MANAMED, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
7
7
2020
5
5
2021
4
4
2022
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3
3
Patient Device Interaction Problem
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Smoking
2
2
Material Integrity Problem
1
1
Output Problem
1
1
Patient-Device Incompatibility
1
1
Insufficient Information
1
1
Power Conditioning Problem
1
1
Material Split, Cut or Torn
1
1
Sparking
1
1
No Apparent Adverse Event
1
1
Overheating of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5
5
Burn(s)
4
4
No Consequences Or Impact To Patient
2
2
Pain
2
2
Patient Problem/Medical Problem
2
2
No Known Impact Or Consequence To Patient
2
2
Partial thickness (Second Degree) Burn
1
1
Skin Inflammation/ Irritation
1
1
Electric Shock
1
1
Blister
1
1
No Patient Involvement
1
1
Discomfort
1
1
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