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 electrode, electrocardiograph
Regulation Description Electrocardiograph electrode.
Product CodeDRX
Regulation Number 870.2360
Device Class 2

MDR Year MDR Reports MDR Events
2020 53 54
2021 55 57
2022 61 62
2023 113 114
2024 61 61
2025 212 212

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 118 119
Biocompatibility 97 97
Insufficient Information 60 60
Connection Problem 41 41
Patient-Device Incompatibility 23 23
Failure to Sense 19 19
Human-Device Interface Problem 14 14
Patient Device Interaction Problem 13 13
Fitting Problem 12 12
Device Sensing Problem 12 12
Use of Device Problem 11 11
Loose or Intermittent Connection 8 8
Failure to Deliver Shock/Stimulation 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Incorrect Interpretation of Signal 7 7
Loss of or Failure to Bond 6 6
Appropriate Term/Code Not Available 6 6
Disconnection 5 5
Improper or Incorrect Procedure or Method 5 5
Overheating of Device 5 5
Product Quality Problem 5 5
Detachment of Device or Device Component 4 4
Defective Component 4 5
Material Integrity Problem 4 4
Failure to Read Input Signal 3 3
Electrical /Electronic Property Problem 3 3
Physical Resistance/Sticking 3 3
Defective Device 3 4
Unable to Obtain Readings 3 3
Defibrillation/Stimulation Problem 2 2
Material Separation 2 2
Component Missing 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Transmit Record 2 2
Peeled/Delaminated 2 2
Output Problem 2 2
Entrapment of Device 2 2
Signal Artifact/Noise 2 2
Adhesive Too Strong 1 1
Positioning Failure 1 2
Material Too Rigid or Stiff 1 1
Shipping Damage or Problem 1 1
Difficult to Remove 1 1
Environmental Compatibility Problem 1 1
Device Handling Problem 1 1
Unintended Movement 1 1
Pacing Inadequately 1 1
Inadequacy of Device Shape and/or Size 1 1
Unintended Electrical Shock 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 172 172
No Clinical Signs, Symptoms or Conditions 139 141
Blister 71 71
Rash 52 53
Itching Sensation 48 48
Skin Tears 29 29
Burn(s) 27 27
Hypersensitivity/Allergic reaction 22 22
Erythema 19 19
Burning Sensation 18 18
Insufficient Information 12 13
Pain 11 11
Localized Skin Lesion 11 11
Skin Burning Sensation 10 10
Partial thickness (Second Degree) Burn 10 10
No Known Impact Or Consequence To Patient 10 10
Superficial (First Degree) Burn 9 9
Skin Irritation 9 9
Bruise/Contusion 8 9
Peeling 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Full thickness (Third Degree) Burn 7 7
Swelling/ Edema 6 6
Skin Discoloration 6 6
No Consequences Or Impact To Patient 5 5
Skin Infection 5 5
Contact Dermatitis 4 4
Caustic/Chemical Burns 4 4
Abrasion 4 4
Irritation 4 4
Hemorrhage/Bleeding 4 4
Reaction 4 5
Asystole 3 3
Skin Erosion 3 3
Foreign Body In Patient 3 3
Scar Tissue 3 3
Discomfort 3 3
Skin Inflammation 3 3
Urticaria 3 3
Anaphylactic Shock 2 2
Unspecified Tissue Injury 2 2
Fluid Discharge 2 2
Sore Throat 2 2
Airway Obstruction 2 2
Fall 2 2
Ecchymosis 2 2
Chest Pain 2 2
Ventricular Fibrillation 2 2
Cardiac Arrest 2 2
Anaphylactoid 2 2

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Nov-01-2021
2 3M Company - Health Care Business II Nov-05-2020
3 Graphic Controls Acquisition Corporation II Apr-14-2022
-
-