Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device alarm, conditioned response enuresis
Product CodeKPN
Regulation Number 876.2040
Device Class 2

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

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 24 24
Leak/Splash 5 5
Melted 5 5
Break 4 4
Device Emits Odor 4 4
Smoking 3 3
Fire 2 2
Defective Component 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Electrical Shorting 2 2
Material Protrusion/Extrusion 2 2
Fluid/Blood Leak 2 2
Device-Device Incompatibility 1 1
Physical Resistance/Sticking 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Moisture Damage 1 1
Battery Problem 1 1
Gas/Air Leak 1 1
Thermal Decomposition of Device 1 1
Product Quality Problem 1 1
Explosion 1 1
Defective Alarm 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 11 11
No Known Impact Or Consequence To Patient 10 10
Pain 4 4
Electric Shock 3 3
Scarring 3 3
Laceration(s) 3 3
Blood Loss 2 2
Burning Sensation 2 2
Injury 2 2
Discomfort 2 2
Non specific EKG/ECG Changes 1 1
Emotional Changes 1 1
Rash 1 1
Irritation 1 1
Burn(s) 1 1
Erythema 1 1
No Patient Involvement 1 1
Swelling 1 1
Therapeutic Response, Decreased 1 1
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1

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