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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
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Excessive Heating
120
120
Labelling, Instructions for Use or Training Problem
118
118
Adverse Event Without Identified Device or Use Problem
89
89
Insufficient Information
74
74
Product Quality Problem
68
68
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
Sparking
15
15
Use of Device Problem
14
14
Device Emits Odor
11
11
Thermal Decomposition of Device
11
11
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
Electrical /Electronic Property Problem
2
2
Electrical Shorting
2
2
Naturally Worn
2
2
Lack of Maintenance Documentation or Guidelines
2
2
Noise, Audible
2
2
Material Puncture/Hole
2
2
Defective Device
2
2
No Apparent Adverse Event
2
2
Unexpected Shutdown
1
1
Key or Button Unresponsive/not Working
1
1
Fail-Safe Did Not Operate
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unintended Electrical Shock
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
Material Frayed
1
1
Component Missing
1
1
Device Remains Activated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
354
354
Insufficient Information
140
140
No Clinical Signs, Symptoms or Conditions
123
123
No Known Impact Or Consequence To Patient
31
31
Superficial (First Degree) Burn
22
22
Partial thickness (Second Degree) Burn
18
18
Full thickness (Third Degree) Burn
15
15
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
Undesired Nerve Stimulation
3
3
Scar Tissue
3
3
Dry Eye(s)
2
2
Unspecified Infection
2
2
Skin Burning Sensation
2
2
Injury
2
2
Fluid Discharge
2
2
Discomfort
2
2
Inadequate Pain Relief
1
1
Skin Discoloration
1
1
Convulsion/Seizure
1
1
Itching Sensation
1
1
No Information
1
1
Erythema
1
1
Irritation
1
1
Dizziness
1
1
Death
1
1
Nerve Damage
1
1
Diaphoresis
1
1
Impaired Healing
1
1
Unspecified Tissue Injury
1
1
Eye Pain
1
1
Hemorrhage/Bleeding
1
1
Myalgia
1
1
Confusion/ Disorientation
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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