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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
2017 17 17
2018 44 44
2019 26 26
2020 25 25
2021 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Break 33 33
Adverse Event Without Identified Device or Use Problem 15 15
Insufficient Information 12 12
Material Fragmentation 11 11
Failure to Read Input Signal 9 9
Difficult to Remove 8 8
Entrapment of Device 7 7
Device Handling Problem 7 7
Component Missing 6 6
Positioning Problem 5 5
Human Factors Issue 5 5
Failure to Disconnect 4 4
Detachment Of Device Component 4 4
Detachment of Device or Device Component 3 3
Device Dislodged or Dislocated 2 2
Separation Failure 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Microbial Contamination of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Physical Resistance/Sticking 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Sticking 1 1
Shelf Life Exceeded 1 1
Difficult to Insert 1 1
No Device Output 1 1
Overheating of Device 1 1
Unable to Obtain Readings 1 1
Device Reprocessing Problem 1 1
Signal Artifact/Noise 1 1
Bent 1 1
Patient Device Interaction Problem 1 1
Scratched Material 1 1
Connection Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 36 36
Post Operative Wound Infection 23 23
Device Embedded In Tissue or Plaque 22 22
Foreign Body In Patient 13 13
Tissue Damage 8 8
Unspecified Infection 7 7
Abrasion 5 5
Head Injury 4 4
Laceration(s) 4 4
Pregnancy 4 4
No Clinical Signs, Symptoms or Conditions 3 3
No Code Available 2 2
Swelling 2 2
No Consequences Or Impact To Patient 2 2
Injury 2 2
Abscess 2 2
Cerebrospinal Fluid Leakage 1 1
Purulent Discharge 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Meningitis 1 1
Vessel Or Plaque, Device Embedded In 1 1
Pain 1 1
Staphylococcus Aureus 1 1
No Information 1 1
Post Traumatic Wound Infection 1 1
Burn, Thermal 1 1
Blood Loss 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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