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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 6 6

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
Fluid/Blood Leak 4 4
Off-Label Use 4 4
Insufficient Information 3 3
Inflation Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Appropriate Term/Code Not Available 3 3
Difficult to Remove 3 3
Material Perforation 3 3
Device Contamination with Chemical or Other Material 3 3
Break 2 2
Unsealed Device Packaging 2 2
Contamination /Decontamination Problem 2 2
Use of Device Problem 2 2
Delivered as Unsterile Product 1 1
Detachment Of Device Component 1 1
Physical Resistance/Sticking 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Patient Device Interaction Problem 1 1
Deflation Problem 1 1
Contamination 1 1
Material Fragmentation 1 1
Obstruction of Flow 1 1
Difficult or Delayed Activation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 29 29
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 12 12
Hemorrhage/Bleeding 11 11
No Known Impact Or Consequence To Patient 8 8
Fever 8 8
Prolapse 8 8
Death 6 6
Insufficient Information 6 6
Unspecified Infection 3 3
Chorioamnionitis 3 3
Fetal Distress 3 3
Laceration(s) 3 3
Death, Intrauterine Fetal 3 3
No Information 2 2
Blood Loss 2 2
Rupture 2 2
Foreign Body In Patient 2 2
Discomfort 2 2
No Patient Involvement 2 2
Bleeding 1 1
Weight Changes 1 1
Uterine Perforation 1 1
Sepsis 1 1
Genital Bleeding 1 1
Hematoma 1 1
Alteration In Body Temperature 1 1
Vaginal Mucosa Damage 1 1
Injury 1 1
Vomiting 1 1
Pain 1 1
Abscess 1 1
Ectopic Heartbeat 1 1
Bacterial Infection 1 1
Facial Nerve Paralysis 1 1
Cervical Changes 1 1
Bruise/Contusion 1 1
Device Embedded In Tissue or Plaque 1 1

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