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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
2016 3 3
2017 17 17
2018 44 44
2019 26 26
2020 25 25
2021 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Break 33 33
Adverse Event Without Identified Device or Use Problem 16 16
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
Microbial Contamination of Device 2 2
Separation Failure 2 2
Defective Device 2 2
Patient-Device Incompatibility 2 2
Therapeutic or Diagnostic Output Failure 2 2
Physical Resistance/Sticking 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Shelf Life Exceeded 1 1
Structural Problem 1 1
Sticking 1 1
Improper or Incorrect Procedure or Method 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
Data Problem 1 1
Connection Problem 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 37 37
Device Embedded In Tissue or Plaque 22 22
Post Operative Wound Infection 22 22
Foreign Body In Patient 14 14
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 3 3
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
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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