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TPLC
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show TPLC since
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Device
extractor, vacuum, fetal
Product Code
HDB
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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