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TPLC
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show TPLC since
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Device
pad, heating, powered
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
2019
205
205
2020
117
117
2021
97
97
2022
133
133
2023
322
322
2024
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Excessive Heating
118
118
Adverse Event Without Identified Device or Use Problem
115
115
Improper or Incorrect Procedure or Method
109
109
Labelling, Instructions for Use or Training Problem
93
93
Insufficient Information
73
73
Fire
69
69
Product Quality Problem
67
67
Sparking
51
51
Overheating of Device
45
45
Nonstandard Device
40
40
Smoking
39
39
Thermal Decomposition of Device
36
36
Break
28
28
Temperature Problem
28
28
Use of Device Problem
24
24
Appropriate Term/Code Not Available
19
19
Material Split, Cut or Torn
17
17
Material Twisted/Bent
14
14
Melted
14
14
Device Emits Odor
13
13
Fail-Safe Problem
11
11
Noise, Audible
11
11
Failure to Shut Off
10
10
Patient-Device Incompatibility
8
8
Patient Device Interaction Problem
7
7
Naturally Worn
6
6
Electrical Shorting
6
6
Material Puncture/Hole
6
6
Material Discolored
5
5
Unexpected Therapeutic Results
5
5
Energy Output Problem
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Protective Measures Problem
3
3
Defective Device
2
2
Material Protrusion/Extrusion
2
2
Therapeutic or Diagnostic Output Failure
2
2
No Apparent Adverse Event
2
2
Failure to Power Up
2
2
Electrical /Electronic Property Problem
2
2
Self-Activation or Keying
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Component Missing
2
2
Deformation Due to Compressive Stress
2
2
Detachment of Device or Device Component
2
2
Flare or Flash
2
2
Lack of Maintenance Documentation or Guidelines
2
2
Device-Device Incompatibility
1
1
Electrical Power Problem
1
1
Failure to Advance
1
1
Arcing
1
1
Defective Component
1
1
Material Frayed
1
1
Loose or Intermittent Connection
1
1
Device Remains Activated
1
1
Material Rupture
1
1
Peeled/Delaminated
1
1
Loss of Power
1
1
Output Problem
1
1
Material Deformation
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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
371
371
Insufficient Information
134
134
No Clinical Signs, Symptoms or Conditions
111
111
No Known Impact Or Consequence To Patient
105
105
No Consequences Or Impact To Patient
63
63
Burn, Thermal
26
26
Superficial (First Degree) Burn
22
22
Partial thickness (Second Degree) Burn
21
21
Full thickness (Third Degree) Burn
13
13
Electric Shock
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Blister
7
7
Pain
5
5
Rash
5
5
Skin Inflammation/ Irritation
4
4
Scar Tissue
3
3
No Information
3
3
Undesired Nerve Stimulation
3
3
Injury
3
3
Discomfort
2
2
Skin Burning Sensation
2
2
Shock
2
2
Death
2
2
Dry Eye(s)
2
2
Unspecified Infection
2
2
Irritation
1
1
Itching Sensation
1
1
Nerve Damage
1
1
Erythema
1
1
Hemorrhage/Bleeding
1
1
Swelling
1
1
Tingling
1
1
Dizziness
1
1
Peeling
1
1
Myalgia
1
1
Fluid Discharge
1
1
Convulsion/Seizure
1
1
Eye Pain
1
1
Confusion/ Disorientation
1
1
Impaired Healing
1
1
Inadequate Pain Relief
1
1
Diaphoresis
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Whele LLC DBA Perch
I
Nov-23-2022
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