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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
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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