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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, circular (spiral), scalp and applicator
Product CodeHGP
Regulation Number 884.2675
Device Class 2

MDR Year MDR Reports MDR Events
2014 3 3
2015 10 10
2016 3 3
2017 17 17
2018 44 44
2019 26 26
2020 25 25
2021 33 33
2022 27 27
2023 8 8
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 37 37
Adverse Event Without Identified Device or Use Problem 21 21
Device Handling Problem 16 16
Insufficient Information 16 16
Material Fragmentation 16 16
Entrapment of Device 9 9
Detachment of Device or Device Component 9 9
Difficult to Remove 9 9
Failure to Read Input Signal 9 9
Detachment Of Device Component 6 6
Component Missing 6 6
Human Factors Issue 5 5
Positioning Problem 5 5
Failure to Disconnect 4 4
Separation Failure 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Use of Device Problem 3 3
Device Operates Differently Than Expected 3 3
Signal Artifact/Noise 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defective Device 2 2
Defective Component 2 2
Connection Problem 2 2
Microbial Contamination of Device 2 2
Unable to Obtain Readings 2 2
Device Contamination with Chemical or Other Material 2 2
Patient-Device Incompatibility 2 2
Difficult or Delayed Separation 2 2
Device Dislodged or Dislocated 2 2
Physical Resistance/Sticking 2 2
Device Inoperable 1 1
Overheating of Device 1 1
Fitting Problem 1 1
Device Reprocessing Problem 1 1
Disconnection 1 1
Patient Device Interaction Problem 1 1
Scratched Material 1 1
Human-Device Interface Problem 1 1
Difficult to Insert 1 1
Sticking 1 1
Incorrect Measurement 1 1
Shelf Life Exceeded 1 1
Structural Problem 1 1
Bent 1 1
Data Problem 1 1
Malposition of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Loose or Intermittent Connection 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 40 40
Post Operative Wound Infection 31 31
Device Embedded In Tissue or Plaque 23 23
No Clinical Signs, Symptoms or Conditions 17 17
Foreign Body In Patient 17 17
Abrasion 12 12
Tissue Damage 11 11
Unspecified Infection 7 7
Laceration(s) 6 6
Needle Stick/Puncture 6 6
Insufficient Information 5 5
Head Injury 4 4
Injury 4 4
Pregnancy 4 4
No Code Available 4 4
Localized Skin Lesion 3 3
Skin Tears 3 3
No Consequences Or Impact To Patient 3 3
Swelling 2 2
Abscess 2 2
Unspecified Tissue Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hematoma 1 1
Purulent Discharge 1 1
Inflammation 1 1
Blood Loss 1 1
Burn, Thermal 1 1
Skin Inflammation/ Irritation 1 1
Staphylococcus Aureus 1 1
No Information 1 1
Post Traumatic Wound Infection 1 1
Nausea 1 1
No Patient Involvement 1 1
Vomiting 1 1
Pain 1 1
Abdominal Pain 1 1
Hair Loss 1 1
Cerebrospinal Fluid Leakage 1 1
Meningitis 1 1
Hemorrhage/Bleeding 1 1
Vessel Or Plaque, Device Embedded In 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America, LLC II May-02-2019
2 Philips North America Llc II Jan-06-2023
3 Vital Signs Devices, a GE Healthcare Company II Nov-16-2012
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