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TPLC
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Device
alarm, conditioned response enuresis
Product Code
KPN
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
Choking
9
9
Shock
9
9
Skin Irritation
9
9
Blood Loss
8
8
No Patient Involvement
8
8
Superficial (First Degree) Burn
8
8
Shock from Patient Lead(s)
7
7
Partial thickness (Second Degree) Burn
6
6
Chemical Exposure
6
6
Bruise/Contusion
6
6
Discomfort
6
6
Burning Sensation
5
5
Hemorrhage/Bleeding
5
5
No Code Available
5
5
Emotional Changes
4
4
Tissue Damage
4
4
No Consequences Or Impact To Patient
4
4
Skin Inflammation
4
4
Skin Discoloration
3
3
Reaction
3
3
Device Embedded In Tissue or Plaque
2
2
Foreign Body In Patient
2
2
Strangulation
2
2
Irritation
2
2
Itching Sensation
2
2
Eye Injury
2
2
Sweating
2
2
Sleep Dysfunction
2
2
Tingling
2
2
Therapeutic Response, Decreased
1
1
Complaint, Ill-Defined
1
1
Eye Burn
1
1
Skin Tears
1
1
Needle Stick/Puncture
1
1
Depression
1
1
Fatigue
1
1
Abrasion
1
1
Dyspnea
1
1
Non specific EKG/ECG Changes
1
1
Scar Tissue
1
1
Patient Problem/Medical Problem
1
1
Alteration In Body Temperature
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
I
Oct-31-2022
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