Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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


Premarket Reviews
ManufacturerDecision
NEOVENTA MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 33 33
2022 27 27
2023 8 8
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Handling Problem 17 17
Insufficient Information 16 16
Material Fragmentation 12 12
Detachment of Device or Device Component 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Use of Device Problem 4 4
Separation Failure 3 3
Defective Component 2 2
Connection Problem 2 2
Signal Artifact/Noise 1 1
Disconnection 1 1
Fitting Problem 1 1
Entrapment of Device 1 1
Defective Device 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unable to Obtain Readings 1 1
Difficult or Delayed Separation 1 1
Incorrect Measurement 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 28 28
No Clinical Signs, Symptoms or Conditions 18 18
Abrasion 10 10
Needle Stick/Puncture 6 6
Insufficient Information 5 5
Localized Skin Lesion 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Foreign Body In Patient 2 2
Laceration(s) 2 2
Unspecified Tissue Injury 2 2
Abdominal Pain 1 1
Nausea 1 1
Skin Inflammation/ Irritation 1 1
Burn, Thermal 1 1
Vomiting 1 1
Hair Loss 1 1
No Consequences Or Impact To Patient 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America Llc II Jan-06-2023
-
-