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 forceps, obstetrical
Regulation Description Obstetric forceps.
Product CodeHDA
Regulation Number 884.4400
Device Class 2

MDR Year MDR Reports MDR Events
2020 15 15
2021 21 21
2022 13 13
2023 30 30
2024 14 14
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 54 54
Detachment of Device or Device Component 46 46
Mechanical Problem 12 12
Difficult to Open or Close 11 11
Adverse Event Without Identified Device or Use Problem 5 5
Failure to Align 5 5
Difficult to Remove 5 5
Physical Resistance/Sticking 4 4
Material Twisted/Bent 3 3
Entrapment of Device 2 2
Mechanics Altered 2 2
Product Quality Problem 2 2
Material Split, Cut or Torn 2 2
Material Protrusion/Extrusion 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 66 66
Unintended Radiation Exposure 9 9
No Consequences Or Impact To Patient 9 9
Foreign Body In Patient 6 6
Insufficient Information 6 6
No Patient Involvement 5 5
Unspecified Tissue Injury 3 3
Fluid Discharge 2 2
Constipation 2 2
Syncope/Fainting 2 2
Abdominal Pain 2 2
Emotional Changes 2 2
Erythema 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Discomfort 2 2
Hematuria 2 2
Nausea 2 2
Pain 2 2
Abnormal Vaginal Discharge 2 2
Dysuria 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Cellulitis 1 1
Purulent Discharge 1 1
Hemorrhage/Bleeding 1 1
Anxiety 1 1
Sleep Dysfunction 1 1
Muscle Weakness 1 1
Dizziness 1 1

-
-