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 catheter, balloon, dilation of cervical canal prior to labor
Definition Mechanical dilation of the cervical canal for labor.
Product CodePFJ
Regulation Number 884.4260
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 3 3
2016 8 8
2017 11 11
2018 12 12
2019 26 26
2020 20 20
2021 15 15
2022 10 10
2023 10 10
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 57 57
Material Rupture 10 10
Material Puncture/Hole 8 8
Device Operates Differently Than Expected 7 7
Material Separation 6 6
Device Contaminated During Manufacture or Shipping 5 5
Off-Label Use 4 4
Fluid/Blood Leak 4 4
Inflation Problem 3 3
Difficult to Remove 3 3
Improper or Incorrect Procedure or Method 3 3
Material Perforation 3 3
Device Contamination with Chemical or Other Material 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Contamination /Decontamination Problem 2 2
Use of Device Problem 2 2
Unsealed Device Packaging 2 2
Break 2 2
Detachment Of Device Component 1 1
Contamination 1 1
Deflation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Delivered as Unsterile Product 1 1
Material Fragmentation 1 1
Obstruction of Flow 1 1
Difficult or Delayed Activation 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Positioning Problem 1 1
Patient Device Interaction Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 29 29
No Clinical Signs, Symptoms or Conditions 17 17
No Consequences Or Impact To Patient 12 12
Hemorrhage/Bleeding 11 11
Fever 8 8
Prolapse 8 8
No Known Impact Or Consequence To Patient 8 8
Death 6 6
Insufficient Information 6 6
Death, Intrauterine Fetal 3 3
Fetal Distress 3 3
Unspecified Infection 3 3
Laceration(s) 3 3
Chorioamnionitis 3 3
Foreign Body In Patient 2 2
No Patient Involvement 2 2
Blood Loss 2 2
Rupture 2 2
Discomfort 2 2
No Information 2 2
Injury 1 1
Weight Changes 1 1
Hematoma 1 1
Alteration In Body Temperature 1 1
Device Embedded In Tissue or Plaque 1 1
Ectopic Heartbeat 1 1
Genital Bleeding 1 1
Pain 1 1
Sepsis 1 1
Uterine Perforation 1 1
Vaginal Mucosa Damage 1 1
Vomiting 1 1
Facial Nerve Paralysis 1 1
Abscess 1 1
Bacterial Infection 1 1
Bleeding 1 1
Bruise/Contusion 1 1
Cervical Changes 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon, Inc. II Jan-06-2016
-
-