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TPLC
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Device
pad, heating, powered
Regulation Description
Powered heating pad.
Product Code
IRT
Regulation Number
890.5740
Device Class
2
Premarket Reviews
Manufacturer
Decision
MIBETEC, GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
117
117
2021
97
97
2022
133
133
2023
322
322
2024
77
77
2025
40
40
Device Problems
MDRs with this Device Problem
Events in those MDRs
Labelling, Instructions for Use or Training Problem
135
135
Excessive Heating
121
121
Adverse Event Without Identified Device or Use Problem
89
89
Insufficient Information
77
77
Product Quality Problem
72
72
Improper or Incorrect Procedure or Method
49
49
Fire
43
43
Nonstandard Device
40
40
Overheating of Device
25
25
Temperature Problem
23
23
Appropriate Term/Code Not Available
20
20
Use of Device Problem
16
16
Sparking
15
15
Device Emits Odor
12
12
Thermal Decomposition of Device
12
12
Smoking
11
11
Fail-Safe Problem
11
11
Break
10
10
Material Twisted/Bent
8
8
Melted
8
8
Patient Device Interaction Problem
7
7
Patient-Device Incompatibility
6
6
Unexpected Therapeutic Results
5
5
Energy Output Problem
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Material Discolored
3
3
Failure to Shut Off
3
3
Protective Measures Problem
2
2
No Apparent Adverse Event
2
2
Naturally Worn
2
2
Noise, Audible
2
2
Lack of Maintenance Documentation or Guidelines
2
2
Electrical /Electronic Property Problem
2
2
Electrical Shorting
2
2
Material Puncture/Hole
2
2
Defective Device
2
2
Therapeutic or Diagnostic Output Failure
1
1
Unintended Electrical Shock
1
1
Unexpected Shutdown
1
1
Fail-Safe Did Not Operate
1
1
Key or Button Unresponsive/not Working
1
1
Material Frayed
1
1
Component Missing
1
1
Insufficient Heating
1
1
Electrical Power Problem
1
1
Device-Device Incompatibility
1
1
Detachment of Device or Device Component
1
1
Failure to Power Up
1
1
Device Remains Activated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
370
370
Insufficient Information
148
148
No Clinical Signs, Symptoms or Conditions
126
126
No Known Impact Or Consequence To Patient
31
31
Superficial (First Degree) Burn
23
23
Partial thickness (Second Degree) Burn
19
19
Full thickness (Third Degree) Burn
16
16
No Consequences Or Impact To Patient
14
14
Burn, Thermal
9
9
Blister
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Pain
6
6
Electric Shock
5
5
Rash
5
5
Skin Inflammation/ Irritation
4
4
Scar Tissue
3
3
Undesired Nerve Stimulation
3
3
Dry Eye(s)
2
2
Unspecified Infection
2
2
Discomfort
2
2
Injury
2
2
Fluid Discharge
2
2
Skin Burning Sensation
2
2
Eye Pain
1
1
Convulsion/Seizure
1
1
No Information
1
1
Dizziness
1
1
Skin Discoloration
1
1
Nerve Damage
1
1
Itching Sensation
1
1
Irritation
1
1
Unspecified Tissue Injury
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Confusion/ Disorientation
1
1
Eye Burn
1
1
Diaphoresis
1
1
Inadequate Pain Relief
1
1
Impaired Healing
1
1
Myalgia
1
1
Hemorrhage/Bleeding
1
1
Erythema
1
1
Death
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
EYE COMFORT CARE LLC
II
Aug-14-2024
2
Whele LLC DBA Perch
I
Nov-23-2022
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