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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
Regulation Description Fetal scalp circular (spiral) electrode 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 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Break 37 37
Tip 22 22
Electrode 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Failure to Read Input Signal 9 9
Entrapment of Device 8 8
Difficult to Remove 8 8
Component Missing 6 6
Detachment Of Device Component 6 6
Human Factors Issue 5 5
Material Fragmentation 4 4
Failure to Disconnect 4 4
Coil 3 3
Detachment of Device or Device Component 3 3
Device Operates Differently Than Expected 3 3
Device Dislodged or Dislocated 2 2
Microbial Contamination of Device 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Therapeutic or Diagnostic Output Failure 2 2
Patient-Device Incompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Physical Resistance/Sticking 2 2
Malposition of Device 1 1
Connection Problem 1 1
Positioning Problem 1 1
Scratched Material 1 1
Data Problem 1 1
Difficult to Insert 1 1
Unable to Obtain Readings 1 1
Sticking 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Patient Device Interaction Problem 1 1
Shelf Life Exceeded 1 1
Device Reprocessing Problem 1 1
Probe 1 1
Signal Artifact/Noise 1 1
Bent 1 1
Structural Problem 1 1
Separation Failure 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 40 40
Device Embedded In Tissue or Plaque 22 22
Foreign Body In Patient 15 15
Tissue Damage 11 11
Unspecified Infection 7 7
Injury 4 4
No Code Available 4 4
Pregnancy 4 4
Skin Tears 3 3
Laceration(s) 3 3
Post Operative Wound Infection 2 2
Swelling 2 2
No Consequences Or Impact To Patient 2 2
Abrasion 2 2
Abscess 2 2
Cerebrospinal Fluid Leakage 1 1
Hematoma 1 1
Inflammation 1 1
Staphylococcus Aureus 1 1
Vessel Or Plaque, Device Embedded In 1 1
Post Traumatic Wound Infection 1 1
No Patient Involvement 1 1
Meningitis 1 1
Pain 1 1
Purulent Discharge 1 1
Hemorrhage/Bleeding 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America, LLC II May-02-2019
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