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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
Material Perforation 3 3
Insufficient Information 3 3
Device Contamination with Chemical or Other Material 3 3
Inflation Problem 3 3
Difficult to Remove 3 3
Improper or Incorrect Procedure or Method 3 3
Appropriate Term/Code Not Available 3 3
Use of Device Problem 2 2
Contamination /Decontamination Problem 2 2
Unsealed Device Packaging 2 2
Break 2 2
Labelling, Instructions for Use or Training Problem 1 1
Difficult or Delayed Activation 1 1
Positioning Problem 1 1
Material Fragmentation 1 1
Material Protrusion/Extrusion 1 1
Patient Device Interaction Problem 1 1
Physical Resistance/Sticking 1 1
Detachment Of Device Component 1 1
Delivered as Unsterile Product 1 1
Obstruction of Flow 1 1
Deflation Problem 1 1
Material Integrity Problem 1 1
Contamination 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
Prolapse 8 8
Fever 8 8
No Known Impact Or Consequence To Patient 8 8
Death 6 6
Insufficient Information 6 6
Unspecified Infection 3 3
Death, Intrauterine Fetal 3 3
Fetal Distress 3 3
Laceration(s) 3 3
Chorioamnionitis 3 3
No Patient Involvement 2 2
Foreign Body In Patient 2 2
Blood Loss 2 2
Discomfort 2 2
Rupture 2 2
No Information 2 2
Bruise/Contusion 1 1
Weight Changes 1 1
Bacterial Infection 1 1
Ectopic Heartbeat 1 1
Hematoma 1 1
Cervical Changes 1 1
Abscess 1 1
Vomiting 1 1
Pain 1 1
Device Embedded In Tissue or Plaque 1 1
Injury 1 1
Bleeding 1 1
Uterine Perforation 1 1
Facial Nerve Paralysis 1 1
Alteration In Body Temperature 1 1
Vaginal Mucosa Damage 1 1
Sepsis 1 1
Genital Bleeding 1 1

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