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TPLC
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Device
instrument, manual, general obstetric-gynecologic
Regulation Description
Obstetric-gynecologic general manual instrument.
Product Code
KOH
Regulation Number
884.4520
Device Class
1
MDR Year
MDR Reports
MDR Events
2021
3
3
2022
5
5
2023
6
6
2024
11
11
2025
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
24
24
Material Split, Cut or Torn
2
2
Defective Device
1
1
Material Deformation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Erosion
11
11
Insufficient Information
8
8
Pain
7
7
Urinary Incontinence
6
6
Abnormal Vaginal Discharge
6
6
Urinary Tract Infection
5
5
Hemorrhage/Bleeding
5
5
Prolapse
5
5
No Clinical Signs, Symptoms or Conditions
4
4
Inflammation
4
4
Constipation
3
3
Adhesion(s)
3
3
Abscess
3
3
Micturition Urgency
3
3
Fistula
2
2
Urinary Frequency
2
2
Unspecified Kidney or Urinary Problem
2
2
Scar Tissue
2
2
Dyspareunia
2
2
Obstruction/Occlusion
2
2
Perforation
2
2
Dizziness
2
2
Abdominal Pain
2
2
Injury
1
1
Fever
1
1
Thrombosis/Thrombus
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Foreign Body In Patient
1
1
Incontinence
1
1
Purulent Discharge
1
1
Flatus
1
1
Urinary Retention
1
1
Hernia
1
1
Anemia
1
1
Malaise
1
1
Muscle Weakness
1
1
Hematoma
1
1
Tachycardia
1
1
Anxiety
1
1
Stenosis
1
1
Swelling/ Edema
1
1
Unspecified Tissue Injury
1
1
Unspecified Heart Problem
1
1
Nausea
1
1
Fatigue
1
1
Wound Dehiscence
1
1
Low Blood Pressure/ Hypotension
1
1
Internal Organ Perforation
1
1
Unspecified Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Apr-23-2021
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