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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
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Labelling, Instructions for Use or Training Problem
125
125
Excessive Heating
120
120
Adverse Event Without Identified Device or Use Problem
89
89
Insufficient Information
74
74
Product Quality Problem
71
71
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
Smoking
11
11
Thermal Decomposition of Device
11
11
Fail-Safe Problem
11
11
Break
10
10
Melted
8
8
Material Twisted/Bent
8
8
Patient Device Interaction Problem
7
7
Patient-Device Incompatibility
6
6
Unexpected Therapeutic Results
5
5
Energy Output Problem
4
4
Material Discolored
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Failure to Shut Off
3
3
Defective Device
2
2
Material Puncture/Hole
2
2
Electrical Shorting
2
2
No Apparent Adverse Event
2
2
Protective Measures Problem
2
2
Naturally Worn
2
2
Lack of Maintenance Documentation or Guidelines
2
2
Electrical /Electronic Property Problem
2
2
Noise, Audible
2
2
Key or Button Unresponsive/not Working
1
1
Failure to Power Up
1
1
Therapeutic or Diagnostic Output Failure
1
1
Component Missing
1
1
Fail-Safe Did Not Operate
1
1
Detachment of Device or Device Component
1
1
Unintended Electrical Shock
1
1
Electrical Power Problem
1
1
Unexpected Shutdown
1
1
Device-Device Incompatibility
1
1
Device Remains Activated
1
1
Material Frayed
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
361
361
Insufficient Information
143
143
No Clinical Signs, Symptoms or Conditions
124
124
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
Scar Tissue
3
3
Undesired Nerve Stimulation
3
3
Unspecified Infection
2
2
Dry Eye(s)
2
2
Injury
2
2
Discomfort
2
2
Fluid Discharge
2
2
Skin Burning Sensation
2
2
Impaired Healing
1
1
Death
1
1
Diaphoresis
1
1
Dizziness
1
1
No Information
1
1
Itching Sensation
1
1
Myalgia
1
1
Skin Discoloration
1
1
Confusion/ Disorientation
1
1
Irritation
1
1
Erythema
1
1
Nerve Damage
1
1
Unspecified Tissue Injury
1
1
Convulsion/Seizure
1
1
Hemorrhage/Bleeding
1
1
Inadequate Pain Relief
1
1
Eye Pain
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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