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TPLC
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show TPLC since
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2024
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Device
instrument, manual, general obstetric-gynecologic
Product Code
KOH
Regulation Number
884.4520
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
1
1
2016
34
34
2017
26
26
2018
4
4
2019
1
1
2021
3
3
2022
5
5
2023
6
6
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
77
77
Material Split, Cut or Torn
3
3
Insufficient Information
3
3
Device Operates Differently Than Expected
2
2
Malposition of Device
1
1
Burst Container or Vessel
1
1
Entrapment of Device
1
1
Material Deformation
1
1
Inflation Problem
1
1
Mechanical Jam
1
1
Defective Device
1
1
Inadequate Instructions for Healthcare Professional
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Information
64
64
Insufficient Information
7
7
Erosion
6
6
Abnormal Vaginal Discharge
6
6
Hemorrhage/Bleeding
5
5
No Clinical Signs, Symptoms or Conditions
4
4
Urinary Incontinence
4
4
Laceration(s)
4
4
Prolapse
3
3
Pain
3
3
Micturition Urgency
3
3
Inflammation
3
3
Adhesion(s)
3
3
Abdominal Pain
3
3
No Known Impact Or Consequence To Patient
2
2
Hematoma
2
2
Dyspareunia
2
2
Scar Tissue
2
2
Abscess
2
2
Unspecified Infection
2
2
No Consequences Or Impact To Patient
2
2
Constipation
2
2
Urinary Tract Infection
2
2
Fistula
2
2
Muscle Weakness
1
1
Malaise
1
1
Anemia
1
1
Obstruction/Occlusion
1
1
Purulent Discharge
1
1
Incontinence
1
1
Foreign Body In Patient
1
1
Injury
1
1
Fever
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Flatus
1
1
Diarrhea
1
1
Dizziness
1
1
Wound Dehiscence
1
1
Tachycardia
1
1
Anxiety
1
1
Stenosis
1
1
Swelling/ Edema
1
1
Unspecified Heart Problem
1
1
Urinary Frequency
1
1
Low Blood Pressure/ Hypotension
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Apr-23-2021
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