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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

MDR Year MDR Reports MDR Events
2016 36 36
2017 54 54
2018 43 43
2019 50 50
2020 53 53
2021 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 76 76
Adverse Event Without Identified Device or Use Problem 50 50
Patient-Device Incompatibility 18 18
Improper or Incorrect Procedure or Method 11 11
Device Sensing Problem 7 7
Failure to Sense 7 7
Appropriate Term/Code Not Available 7 7
Missing Value Reason 6 6
Device Operates Differently Than Expected 6 6
Incorrect Interpretation of Signal 6 6
Material Separation 4 4
Component Missing 4 4
Break 4 4
Unable to Obtain Readings 4 4
Defective Component 4 4
Disconnection 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Detachment of Device or Device Component 3 3
Device Handling Problem 3 3
Patient Device Interaction Problem 2 2
Mechanical Jam 2 2
No Apparent Adverse Event 2 2
Incomplete or Missing Packaging 2 2
Use of Device Problem 2 2
Mechanical Problem 2 2
Physical Resistance/Sticking 2 2
Failure to Read Input Signal 2 2
Connection Problem 1 1
Device Fell 1 1
Missing Information 1 1
Device-Device Incompatibility 1 1
Electrical Power Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Electrical /Electronic Property Problem 1 1
Entrapment of Device 1 1
Failure to Transmit Record 1 1
Device Appears to Trigger Rejection 1 1
Failure To Adhere Or Bond 1 1
Premature Discharge of Battery 1 1
Thermal Decomposition of Device 1 1
Detachment Of Device Component 1 1
Overheating of Device 1 1
Pacing Inadequately 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
Failure to Discharge 1 1
False Reading From Device Non-Compliance 1 1
Gel Leak 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
Device Packaging Compromised 1 1
Physical Property Issue 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Irritation 45 45
No Known Impact Or Consequence To Patient 35 35
Rash 29 29
Itching Sensation 23 23
Burn(s) 20 20
Skin Tears 18 18
Burning Sensation 14 14
Reaction 13 13
Lead(s), Burn(s) From 13 13
Erythema 13 13
Hypersensitivity/Allergic reaction 12 12
No Information 12 12
No Clinical Signs, Symptoms or Conditions 11 11
Irritation 8 8
No Consequences Or Impact To Patient 8 8
Pain 6 6
Death 6 6
Scarring 5 5
Full thickness (Third Degree) Burn 5 5
Skin Inflammation 5 5
Partial thickness (Second Degree) Burn 5 5
Skin Discoloration 4 4
Tissue Damage 4 4
Unspecified Infection 4 4
Bruise/Contusion 3 3
Blister 3 3
Skin Inflammation/ Irritation 3 3
No Patient Involvement 3 3
Foreign Body In Patient 3 3
Discharge 3 3
Superficial (First Degree) Burn 3 3
Insufficient Information 2 2
Swelling 2 2
Abrasion 2 2
Dyspnea 2 2
Patient Problem/Medical Problem 2 2
Discomfort 2 2
Injury 2 2
Sore Throat 2 2
Skin Infection 2 2
Burn, Thermal 2 2
Local Reaction 2 2
Scar Tissue 2 2
Nausea 2 2
Necrosis 1 1
Dizziness 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Asthma 1 1
Purulent Discharge 1 1
Hair Loss 1 1
Hemorrhage/Bleeding 1 1
Hyperemia 1 1
Localized Skin Lesion 1 1
Shaking/Tremors 1 1
Tissue Breakdown 1 1
Dysphagia/ Odynophagia 1 1
Peeling 1 1
Sudden Cardiac Death 1 1
Rupture 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Caustic/Chemical Burns 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Nov-05-2020
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