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TPLC
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Device
forceps, obstetrical
Regulation Description
Obstetric forceps.
Product Code
HDA
Regulation Number
884.4400
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
15
15
2021
21
21
2022
13
13
2023
30
30
2024
14
14
2025
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
54
54
Detachment of Device or Device Component
46
46
Mechanical Problem
12
12
Difficult to Open or Close
11
11
Adverse Event Without Identified Device or Use Problem
5
5
Failure to Align
5
5
Difficult to Remove
5
5
Physical Resistance/Sticking
4
4
Material Twisted/Bent
3
3
Entrapment of Device
2
2
Mechanics Altered
2
2
Product Quality Problem
2
2
Material Split, Cut or Torn
2
2
Material Protrusion/Extrusion
1
1
Insufficient Information
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Difficult to Insert
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
66
66
Unintended Radiation Exposure
9
9
No Consequences Or Impact To Patient
9
9
Foreign Body In Patient
6
6
Insufficient Information
6
6
No Patient Involvement
5
5
Unspecified Tissue Injury
3
3
Fluid Discharge
2
2
Constipation
2
2
Syncope/Fainting
2
2
Abdominal Pain
2
2
Emotional Changes
2
2
Erythema
2
2
Cramp(s) /Muscle Spasm(s)
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Discomfort
2
2
Hematuria
2
2
Nausea
2
2
Pain
2
2
Abnormal Vaginal Discharge
2
2
Dysuria
1
1
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
Cellulitis
1
1
Purulent Discharge
1
1
Hemorrhage/Bleeding
1
1
Anxiety
1
1
Sleep Dysfunction
1
1
Muscle Weakness
1
1
Dizziness
1
1
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