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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
2018 44 44
2019 26 26
2020 25 25
2021 33 33
2022 27 27
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 29 29
Adverse Event Without Identified Device or Use Problem 20 20
Insufficient Information 16 16
Device Handling Problem 16 16
Material Fragmentation 15 15
Failure to Read Input Signal 9 9
Detachment of Device or Device Component 8 8
Difficult to Remove 7 7
Component Missing 6 6
Entrapment of Device 6 6
Positioning Problem 5 5
Failure to Disconnect 4 4
Separation Failure 4 4
Detachment Of Device Component 3 3
Use of Device Problem 2 2
Defective Component 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Device Dislodged or Dislocated 2 2
Unable to Obtain Readings 2 2
Therapeutic or Diagnostic Output Failure 2 2
Physical Resistance/Sticking 2 2
Difficult or Delayed Separation 2 2
Patient Device Interaction Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Scratched Material 1 1
Connection Problem 1 1
Structural Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Shelf Life Exceeded 1 1
Sticking 1 1
Signal Artifact/Noise 1 1
Loose or Intermittent Connection 1 1
No Device Output 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 32 32
Post Operative Wound Infection 31 31
Device Embedded In Tissue or Plaque 16 16
Foreign Body In Patient 12 12
Abrasion 12 12
No Clinical Signs, Symptoms or Conditions 9 9
Tissue Damage 7 7
Laceration(s) 6 6
Needle Stick/Puncture 6 6
Pregnancy 4 4
Insufficient Information 4 4
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 Code Available 2 2
Unspecified Infection 2 2
Abscess 2 2
Swelling 2 2
No Consequences Or Impact To Patient 2 2
Injury 1 1
Meningitis 1 1
Vessel Or Plaque, Device Embedded In 1 1
Staphylococcus Aureus 1 1
Cerebrospinal Fluid Leakage 1 1
Purulent Discharge 1 1
Hair Loss 1 1
Inflammation 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
No Information 1 1
Burn, Thermal 1 1
Blood Loss 1 1
Post Traumatic Wound Infection 1 1
Skin Inflammation/ Irritation 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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