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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
Insufficient Information 16 16
Device Handling Problem 16 16
Material Fragmentation 16 16
Failure to Read Input Signal 9 9
Entrapment of Device 9 9
Difficult to Remove 9 9
Detachment of Device or Device Component 9 9
Component Missing 6 6
Detachment Of Device Component 6 6
Positioning Problem 5 5
Human Factors Issue 5 5
Failure to Disconnect 4 4
Separation Failure 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Operates Differently Than Expected 3 3
Use of Device Problem 3 3
Signal Artifact/Noise 2 2
Physical Resistance/Sticking 2 2
Patient-Device Incompatibility 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defective Component 2 2
Defective Device 2 2
Microbial Contamination of Device 2 2
Device Dislodged or Dislocated 2 2
Difficult or Delayed Separation 2 2
Connection Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Unable to Obtain Readings 2 2
Improper or Incorrect Procedure or Method 1 1
Loose or Intermittent Connection 1 1
Device Inoperable 1 1
Overheating of Device 1 1
Incorrect Measurement 1 1
Sticking 1 1
Difficult to Insert 1 1
Shelf Life Exceeded 1 1
No Device Output 1 1
Device Reprocessing Problem 1 1
Human-Device Interface Problem 1 1
Bent 1 1
Data Problem 1 1
Structural Problem 1 1
Scratched Material 1 1
Patient Device Interaction Problem 1 1
Malposition of Device 1 1
Disconnection 1 1
Fitting Problem 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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