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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
2019 31 31
2020 24 24
2021 21 21
2022 12 12
2023 24 24
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Break 26 26
Insufficient Information 18 18
Use of Device Problem 14 14
Suction Failure 11 11
Adverse Event Without Identified Device or Use Problem 7 7
Detachment of Device or Device Component 7 7
Suction Problem 7 7
Mechanical Problem 6 6
Defective Component 6 6
Therapeutic or Diagnostic Output Failure 6 6
Pressure Problem 4 4
Appropriate Term/Code Not Available 4 4
Defective Device 3 3
Decrease in Suction 3 3
Material Rupture 3 3
Product Quality Problem 3 3
Material Separation 3 3
Material Split, Cut or Torn 2 2
Device Dislodged or Dislocated 2 2
Disconnection 1 1
Leak/Splash 1 1
Device Slipped 1 1
Fitting Problem 1 1
Output Problem 1 1
Activation Problem 1 1
Crack 1 1
Pumping Problem 1 1
Expiration Date Error 1 1
Deflation Problem 1 1
Material Fragmentation 1 1
No Pressure 1 1
Component Missing 1 1
Dent in Material 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Failure to Deflate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
No Known Impact Or Consequence To Patient 22 22
Insufficient Information 20 20
Cephalohematoma 11 11
Hematoma 9 9
Laceration(s) 9 9
Hemorrhage, Subgaleal 6 6
No Consequences Or Impact To Patient 5 5
Hemorrhage/Bleeding 4 4
Intracranial Hemorrhage 3 3
Skull Fracture 3 3
Fetal Distress 3 3
No Information 3 3
No Code Available 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Injury 2 2
Vaginal Mucosa Damage 2 2
Bone Fracture(s) 2 2
Bruise/Contusion 2 2
Death 2 2
Edema 1 1
Encephalopathy 1 1
Extreme Exhaustion 1 1
Perinatal Brain Injury 1 1
Abrasion 1 1
Bradycardia 1 1
Swelling 1 1
Shock, Traumatic 1 1
Hemorrhage, Subarachnoid 1 1
Hypoxia 1 1
Deformity/ Disfigurement 1 1
Blister 1 1
Easy Bruising 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1

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