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TPLC
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show TPLC since
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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
2023
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
69
69
Break
24
24
Material Separation
16
16
Appropriate Term/Code Not Available
2
2
Migration
2
2
Detachment Of Device Component
2
2
Defective Component
2
2
Defective Device
1
1
Patient-Device Incompatibility
1
1
Connection Problem
1
1
Device Markings/Labelling Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Contamination
1
1
Crack
1
1
Migration or Expulsion of Device
1
1
Delivered as Unsterile Product
1
1
Unsealed Device Packaging
1
1
Use of Device Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Not Applicable
32
32
No Clinical Signs, Symptoms or Conditions
25
25
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
Injury
5
5
No Code Available
5
5
Hematoma
4
4
Wound Dehiscence
4
4
Sepsis
4
4
Laceration(s)
4
4
Inflammation
3
3
Fistula
3
3
Premature Labor
3
3
Abnormal Vaginal Discharge
3
3
Obstruction/Occlusion
3
3
Foreign Body In Patient
2
2
Urinary Frequency
2
2
Discomfort
2
2
Hernia
2
2
Insufficient Information
2
2
Fever
2
2
Micturition Urgency
2
2
Failure of Implant
2
2
Abdominal Pain
2
2
Calcium Deposits/Calcification
2
2
Miscarriage
2
2
Seroma
2
2
Scar Tissue
2
2
Urinary Retention
2
2
Uterine Perforation
1
1
Skin Irritation
1
1
Swelling
1
1
Septic Shock
1
1
Necrosis
1
1
Perforation
1
1
Pocket Erosion
1
1
Menstrual Irregularities
1
1
Cerebrospinal Fluid Leakage
1
1
Death
1
1
Purulent Discharge
1
1
Edema
1
1
Abscess
1
1
Adhesion(s)
1
1
Incontinence
1
1
Failure to Anastomose
1
1
Foreign Body Reaction
1
1
Gastrointestinal Hemorrhage
1
1
Unspecified Tissue Injury
1
1
Therapeutic Response, Decreased
1
1
Rupture
1
1
Impaired Healing
1
1
No Patient Involvement
1
1
Hematuria
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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