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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device extractor, vacuum, fetal
Product CodeHDB
Regulation Number 884.4340
Device Class 2

MDR Year MDR Reports MDR Events
2014 11 11
2015 13 13
2016 15 15
2017 16 16
2018 25 25
2019 31 31
2020 24 24
2021 21 21
2022 12 12
2023 24 24
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 39 39
Insufficient Information 27 27
Device Operates Differently Than Expected 19 19
Suction Problem 15 15
Use of Device Problem 15 15
Suction Failure 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Detachment of Device or Device Component 11 11
Decrease in Suction 8 8
Appropriate Term/Code Not Available 8 8
Detachment Of Device Component 7 7
Material Separation 7 7
Therapeutic or Diagnostic Output Failure 6 6
Defective Component 6 6
Mechanical Problem 5 5
Pressure Problem 4 4
Defective Device 4 4
Product Quality Problem 3 3
Material Rupture 3 3
Difficult to Remove 3 3
No Pressure 2 2
Material Fragmentation 2 2
Pumping Problem 2 2
Dent in Material 2 2
Crack 2 2
Disconnection 2 2
Sticking 2 2
Failure to Pump 2 2
Material Split, Cut or Torn 2 2
Entrapment of Device 2 2
Device Dislodged or Dislocated 2 2
Device Inoperable 2 2
Expiration Date Error 1 1
Material Integrity Problem 1 1
Deflation Problem 1 1
Failure To Adhere Or Bond 1 1
Unintended Ejection 1 1
Component Missing 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Fitting Problem 1 1
Device Slipped 1 1
Device Contamination with Chemical or Other Material 1 1
Leak/Splash 1 1
Activation Problem 1 1
Output Problem 1 1
Activation, Positioning or Separation Problem 1 1
Increase in Suction 1 1
Protective Measures Problem 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 46 46
No Clinical Signs, Symptoms or Conditions 26 26
Insufficient Information 19 19
No Consequences Or Impact To Patient 15 15
Cephalohematoma 15 15
Hemorrhage, Subgaleal 12 12
Hematoma 12 12
Laceration(s) 11 11
No Information 9 9
Death 7 7
Hemorrhage/Bleeding 6 6
No Code Available 6 6
Skull Fracture 6 6
Bone Fracture(s) 4 4
Abrasion 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Fetal Distress 3 3
Perinatal Brain Injury 3 3
Intracranial Hemorrhage 3 3
Bruise/Contusion 2 2
Bradycardia 2 2
No Patient Involvement 2 2
Injury 2 2
Vaginal Mucosa Damage 2 2
Hemorrhage, Subdural 2 2
Rupture 2 2
Suffocation 2 2
Blister 1 1
Pallor 1 1
Easy Bruising 1 1
Edema 1 1
Foreign Body In Patient 1 1
Exposure to Body Fluids 1 1
Swelling 1 1
Head Injury 1 1
Occlusion 1 1
Brain Injury 1 1
Pain 1 1
Shock, Traumatic 1 1
Tachycardia 1 1
Tissue Damage 1 1
Hypoxia 1 1
Extreme Exhaustion 1 1
Encephalopathy 1 1
Bacterial Infection 1 1
Hemorrhage, Subarachnoid 1 1
Deformity/ Disfigurement 1 1
Hypoxia in Utero 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Clinical Innovations, LLC II May-21-2020
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