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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pad, heating, powered
Regulation Description Powered heating pad.
Product CodeIRT
Regulation Number 890.5740
Device Class 2

MDR Year MDR Reports MDR Events
2016 182 182
2017 220 220
2018 325 325
2019 205 205
2020 118 118

Device Problems MDRs with this Device Problem Events in those MDRs
Fire 237 237
Improper or Incorrect Procedure or Method 230 230
Adverse Event Without Identified Device or Use Problem 172 172
Sparking 126 126
Thermal Decomposition of Device 116 116
Cord 94 94
Pad 78 78
Smoking 77 77
Break 61 61
Overheating of Device 56 56
Use of Device Problem 56 56
Insufficient Information 56 56
Device Emits Odor 48 48
Heater 48 48
Melted 35 35
Bent 27 27
Material Twisted/Bent 27 27
Failure to Shut Off 21 21
Switches 21 21
Material Split, Cut or Torn 20 20
Device Operates Differently Than Expected 19 19
Controller 19 19
Material Discolored 19 19
Cut In Material 19 19
Crack 18 18
Wire 18 18
Temperature Problem 18 18
Noise, Audible 17 17
Switch, Push Button 17 17
Power Cord 14 14
Hole In Material 14 14
Patient Lead 10 10
Electrical /Electronic Property Problem 9 9
Cover 8 8
Patient-Device Incompatibility 8 8
Naturally Worn 8 8
Electrical Shorting 8 8
Inappropriate/Inadequate Shock/Stimulation 7 7
Material Puncture/Hole 7 7
Flare or Flash 6 6
Excessive Heating 6 6
Device Inoperable 5 5
Housing 5 5
Burst Container or Vessel 5 5
Insufficient Heating 4 4
Thermostat 4 4
Appropriate Term/Code Not Available 4 4
Material Protrusion/Extrusion 4 4
Torn Material 3 3
Material Deformation 3 3
Loss of Power 3 3
Self-Activation or Keying 3 3
Structural Problem 3 3
Folded 3 3
Detachment Of Device Component 3 3
Clip 3 3
Loose or Intermittent Connection 2 2
Fluid Leak 2 2
Deformation Due to Compressive Stress 2 2
Split 2 2
Defective Component 2 2
Component Missing 2 2
Material Separation 2 2
Device Stops Intermittently 2 2
Failure to Power Up 2 2
Nonstandard Device 2 2
Human Factors Issue 2 2
Detachment of Device or Device Component 2 2
Electrical Wire 2 2
Circuit Breaker 1 1
Device Component Or Accessory 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Contamination with Chemical or Other Material 1 1
Device Packaging Compromised 1 1
Device Unsafe to Use in Environment 1 1
Device Dislodged or Dislocated 1 1
Mechanics Altered 1 1
Output Problem 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Device Remains Activated 1 1
Material Rupture 1 1
Out-Of-Box Failure 1 1
Failure to Advance 1 1
Arcing 1 1
Failure to Cut 1 1
Failure to Fire 1 1
Connection Problem 1 1
Entrapment of Device 1 1
No Display/Image 1 1
Contamination 1 1
Circuit Failure 1 1
Cable, Electrical 1 1
Scale 1 1
Slide 1 1
Spring 1 1
Power Switch 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 331 331
No Known Impact Or Consequence To Patient 317 317
No Consequences Or Impact To Patient 192 192
Burn, Thermal 56 56
Partial thickness (Second Degree) Burn 48 48
No Information 42 42
Full thickness (Third Degree) Burn 25 25
Electric Shock 11 11
Injury 9 9
No Clinical Signs, Symptoms or Conditions 9 9
Superficial (First Degree) Burn 6 6
Burning Sensation 4 4
Death 4 4
Pain 4 4
Unspecified Infection 3 3
Shock 3 3
Not Applicable 3 3
No Code Available 3 3
Insufficient Information 3 3
Swelling 2 2
Laceration(s) 2 2
Nausea 2 2
Scarring 2 2
Electrocution 1 1
Headache 1 1
Nerve Damage 1 1
Bruise/Contusion 1 1
Tingling 1 1
Discomfort 1 1
No Patient Involvement 1 1
Alteration In Body Temperature 1 1
Respiratory Acidosis 1 1
Sleep Dysfunction 1 1
Erythema 1 1
Irritation 1 1
Peeling 1 1
Shock from Patient Lead(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 2k Innovations Inc. II Apr-12-2017
2 Battle Creek Equipment Co. II Nov-03-2016
3 Ergoactives, Llc II Jul-07-2016
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