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TPLC
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show TPLC since
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Device
source, brachytherapy, radionuclide
Product Code
KXK
Regulation Number
892.5730
Device Class
2
Premarket Reviews
Manufacturer
Decision
CIVATECH ONCOLOGY INC.
SUBSTANTIALLY EQUIVALENT
1
GT MEDICAL TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
3
ISORAY MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
LV LIBERTY VISION CORPORATION
SUBSTANTIALLY EQUIVALENT
1
RADIANCE THERAPEUTICS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
10
10
2020
15
15
2021
62
62
2022
26
26
2023
9
9
2024
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Physical Resistance/Sticking
59
59
Inaccurate Information
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Inadequate Instructions for Healthcare Professional
5
5
Device Contamination with Chemical or Other Material
5
5
Positioning Failure
5
5
Component Missing
4
4
Fitting Problem
3
3
Output Problem
3
3
Mechanical Jam
3
3
Lack of Maintenance Documentation or Guidelines
3
3
Insufficient Information
3
3
Missing Information
3
3
Labelling, Instructions for Use or Training Problem
3
3
Material Twisted/Bent
3
3
Failure to Discharge
2
2
Break
2
2
Device Markings/Labelling Problem
2
2
Wrong Label
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Integrity Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Packaging Problem
2
2
Appropriate Term/Code Not Available
1
1
Failure to Advance
1
1
Component Misassembled
1
1
Installation-Related Problem
1
1
Detachment of Device or Device Component
1
1
Material Deformation
1
1
Unintended Ejection
1
1
Difficult to Insert
1
1
Material Fragmentation
1
1
Microbial Contamination of Device
1
1
Contamination
1
1
Radiation Overexposure
1
1
Positioning Problem
1
1
Defective Device
1
1
Unsealed Device Packaging
1
1
Unclear Information
1
1
Patient-Device Incompatibility
1
1
Accessory Incompatible
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
99
99
No Known Impact Or Consequence To Patient
12
12
No Consequences Or Impact To Patient
10
10
No Patient Involvement
8
8
Post Operative Wound Infection
6
6
Necrosis
3
3
Unintended Radiation Exposure
3
3
Needle Stick/Puncture
2
2
Insufficient Information
2
2
Cerebral Edema
2
2
Unspecified Infection
1
1
Death
1
1
Arthralgia
1
1
Urinary Incontinence
1
1
Inflammation
1
1
Incontinence
1
1
Urinary Retention
1
1
Dyspnea
1
1
Pain
1
1
Myocardial Infarction
1
1
Ambulation Difficulties
1
1
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