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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
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
Adverse Event Without Identified Device or Use Problem 18 18
Insufficient Information 16 16
Device Handling Problem 16 16
Material Fragmentation 12 12
Break 9 9
Detachment of Device or Device Component 8 8
Component Missing 6 6
Entrapment of Device 5 5
Positioning Problem 5 5
Separation Failure 4 4
Difficult to Remove 4 4
Use of Device Problem 3 3
Physical Resistance/Sticking 2 2
Patient-Device Incompatibility 2 2
Defective Component 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unable to Obtain Readings 2 2
Difficult or Delayed Separation 2 2
Device Dislodged or Dislocated 2 2
Signal Artifact/Noise 1 1
Disconnection 1 1
Fitting Problem 1 1
Defective Device 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Scratched Material 1 1
Structural Problem 1 1
Incorrect Measurement 1 1
Connection Problem 1 1
Human-Device Interface Problem 1 1
Overheating of Device 1 1
Loose or Intermittent Connection 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Post Operative Wound Infection 31 31
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 13 13
Abrasion 12 12
Foreign Body In Patient 8 8
Device Embedded In Tissue or Plaque 7 7
Needle Stick/Puncture 6 6
Laceration(s) 6 6
Insufficient Information 5 5
Tissue Damage 5 5
Head Injury 4 4
Localized Skin Lesion 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 2 2
No Consequences Or Impact To Patient 2 2
Vessel Or Plaque, Device Embedded In 1 1
Abdominal Pain 1 1
Unspecified Infection 1 1
Nausea 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1
Hematoma 1 1
Burn, Thermal 1 1
Blood Loss 1 1
Post Traumatic Wound Infection 1 1
Injury 1 1
Swelling 1 1
Vomiting 1 1
Hair Loss 1 1
Cerebrospinal Fluid Leakage 1 1
Hemorrhage/Bleeding 1 1
Meningitis 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
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