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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device alarm, conditioned response enuresis
Product CodeKPN
Regulation Number 876.2040
Device Class 2

MDR Year MDR Reports MDR Events
2019 423 423
2020 36 36
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 266 266
Leak/Splash 64 64
Device Emits Odor 58 58
Temperature Problem 54 54
Defective Component 36 36
Break 33 33
Defective Device 29 29
Inappropriate/Inadequate Shock/Stimulation 27 27
Vibration 22 22
Thermal Decomposition of Device 22 22
Noise, Audible 16 16
Material Twisted/Bent 15 15
Melted 15 15
Electrical Shorting 14 14
Patient-Device Incompatibility 12 12
Battery Problem 11 11
Device Alarm System 11 11
Smoking 9 9
Scratched Material 8 8
Malposition of Device 7 7
Detachment of Device or Device Component 7 7
Material Deformation 6 6
Material Protrusion/Extrusion 6 6
Unintended Electrical Shock 6 6
Fluid/Blood Leak 6 6
Display or Visual Feedback Problem 6 6
Burst Container or Vessel 5 5
Fire 5 5
Product Quality Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Explosion 4 4
Physical Resistance/Sticking 4 4
Device Fell 4 4
Excessive Heating 4 4
Device Dislodged or Dislocated 4 4
Unstable 4 4
Material Rupture 3 3
Defective Alarm 3 3
Electrical /Electronic Property Problem 3 3
Deformation Due to Compressive Stress 3 3
Failure to Shut Off 3 3
Therapeutic or Diagnostic Output Failure 3 3
Protective Measures Problem 2 2
Failure to Power Up 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Circuit Failure 2 2
Crack 2 2
Self-Activation or Keying 2 2
Difficult to Remove 2 2
Moisture Damage 2 2
Loss of Power 1 1
No Audible Prompt/Feedback 1 1
Use of Device Problem 1 1
Degraded 1 1
Erratic or Intermittent Display 1 1
No Audible Alarm 1 1
Premature Discharge of Battery 1 1
False Alarm 1 1
Material Fragmentation 1 1
Gel Leak 1 1
Entrapment of Device 1 1
Unintended Ejection 1 1
Material Integrity Problem 1 1
Gas/Air Leak 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Electrical Power Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 153 153
No Known Impact Or Consequence To Patient 126 126
Pain 56 56
Injury 26 26
Electric Shock 24 24
Scarring 18 18
Burn(s) 18 18
Erythema 16 16
Rash 14 14
Laceration(s) 14 14
Swelling 11 11
No Information 10 10
Skin Irritation 9 9
Shock 9 9
Choking 9 9
No Patient Involvement 8 8
Superficial (First Degree) Burn 8 8
Blood Loss 8 8
Shock from Patient Lead(s) 7 7
Partial thickness (Second Degree) Burn 6 6
Discomfort 6 6
Bruise/Contusion 6 6
Chemical Exposure 6 6
No Code Available 5 5
Burning Sensation 5 5
Hemorrhage/Bleeding 5 5
Skin Inflammation 4 4
No Consequences Or Impact To Patient 4 4
Emotional Changes 4 4
Tissue Damage 4 4
Skin Discoloration 3 3
Reaction 3 3
Eye Injury 2 2
Sleep Dysfunction 2 2
Foreign Body In Patient 2 2
Strangulation 2 2
Irritation 2 2
Tingling 2 2
Device Embedded In Tissue or Plaque 2 2
Itching Sensation 2 2
Sweating 2 2
Depression 1 1
Needle Stick/Puncture 1 1
Therapeutic Response, Decreased 1 1
Patient Problem/Medical Problem 1 1
Dyspnea 1 1
Skin Tears 1 1
Eye Burn 1 1
Abrasion 1 1
Fatigue 1 1
Non specific EKG/ECG Changes 1 1
Alteration In Body Temperature 1 1
Complaint, Ill-Defined 1 1
Scar Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Oct-31-2022
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