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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

MDR Year MDR Reports MDR Events
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 45 45
Device Contaminated During Manufacture or Shipping 5 5
Material Rupture 5 5
Material Separation 5 5
Off-Label Use 4 4
Material Puncture/Hole 4 4
Fluid/Blood Leak 4 4
Inflation Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Appropriate Term/Code Not Available 3 3
Improper or Incorrect Procedure or Method 3 3
Break 2 2
Unsealed Device Packaging 2 2
Difficult to Remove 2 2
Contamination /Decontamination Problem 2 2
Use of Device Problem 2 2
Physical Resistance/Sticking 1 1
Contamination 1 1
Deflation Problem 1 1
Patient Device Interaction Problem 1 1
Material Fragmentation 1 1
Obstruction of Flow 1 1
Difficult or Delayed Activation 1 1
Material Perforation 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 25 25
No Clinical Signs, Symptoms or Conditions 18 18
Hemorrhage/Bleeding 10 10
Insufficient Information 6 6
Prolapse 6 6
Death 5 5
Fever 5 5
Unspecified Infection 3 3
Fetal Distress 3 3
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 3 3
Rupture 2 2
Foreign Body In Patient 2 2
No Patient Involvement 2 2
Laceration(s) 2 2
Uterine Perforation 1 1
Weight Changes 1 1
Chorioamnionitis 1 1
Genital Bleeding 1 1
Vaginal Mucosa Damage 1 1
Alteration In Body Temperature 1 1
Injury 1 1
Vomiting 1 1
Pain 1 1
Abscess 1 1
Ectopic Heartbeat 1 1
Cervical Changes 1 1
Bruise/Contusion 1 1
Death, Intrauterine Fetal 1 1
Device Embedded In Tissue or Plaque 1 1

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