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TPLC
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show TPLC since
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2023
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Device
instrument, surgical, disposable
Product Code
KDC
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
71
71
2019
16
16
2020
13
13
2021
11
11
2022
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
68
68
Break
19
19
Material Separation
16
16
Detachment Of Device Component
2
2
Defective Component
2
2
Migration
2
2
Appropriate Term/Code Not Available
2
2
Crack
1
1
Use of Device Problem
1
1
Defective Device
1
1
Therapeutic or Diagnostic Output Failure
1
1
Insufficient Information
1
1
Delivered as Unsterile Product
1
1
Connection Problem
1
1
Device Markings/Labelling Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Contamination
1
1
Patient-Device Incompatibility
1
1
Migration or Expulsion of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Not Applicable
32
32
No Clinical Signs, Symptoms or Conditions
19
19
Pain
18
18
Blood Loss
13
13
Unspecified Infection
12
12
No Consequences Or Impact To Patient
11
11
No Known Impact Or Consequence To Patient
8
8
Post Operative Wound Infection
8
8
Urinary Tract Infection
7
7
Bacterial Infection
7
7
Erosion
7
7
Hemorrhage/Bleeding
5
5
No Code Available
5
5
Injury
5
5
Laceration(s)
4
4
Wound Dehiscence
4
4
Sepsis
4
4
Hematoma
4
4
Inflammation
3
3
Abnormal Vaginal Discharge
3
3
Obstruction/Occlusion
3
3
Fistula
3
3
Premature Labor
3
3
Scar Tissue
2
2
Discomfort
2
2
Miscarriage
2
2
Fever
2
2
Calcium Deposits/Calcification
2
2
Insufficient Information
2
2
Hernia
2
2
Foreign Body In Patient
2
2
Seroma
2
2
Urinary Retention
2
2
Abdominal Pain
2
2
Micturition Urgency
2
2
Urinary Frequency
2
2
Failure to Anastomose
1
1
Menstrual Irregularities
1
1
Septic Shock
1
1
Swelling
1
1
Necrosis
1
1
Death
1
1
Edema
1
1
Foreign Body Reaction
1
1
Uterine Perforation
1
1
Therapeutic Response, Decreased
1
1
Gastrointestinal Hemorrhage
1
1
Unspecified Tissue Injury
1
1
Hematuria
1
1
Rupture
1
1
Cerebrospinal Fluid Leakage
1
1
Abscess
1
1
Failure of Implant
1
1
Perforation
1
1
Skin Irritation
1
1
Pocket Erosion
1
1
Incontinence
1
1
Adhesion(s)
1
1
Purulent Discharge
1
1
Impaired Healing
1
1
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medical Action Industries, Inc. 306
II
Dec-22-2022
2
Medical Action Industries, Inc. 306
II
Jun-24-2021
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