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TPLC
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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
6
6
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
Positioning Failure
5
5
Inadequate Instructions for Healthcare Professional
5
5
Component Missing
4
4
Device Contamination with Chemical or Other Material
4
4
Fitting Problem
3
3
Output Problem
3
3
Lack of Maintenance Documentation or Guidelines
3
3
Insufficient Information
3
3
Labelling, Instructions for Use or Training Problem
3
3
Missing Information
3
3
Manufacturing, Packaging or Shipping Problem
2
2
Material Integrity Problem
2
2
Material Twisted/Bent
2
2
Mechanical Jam
2
2
Packaging Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Failure to Discharge
2
2
Material Fragmentation
1
1
Difficult to Insert
1
1
Unsealed Device Packaging
1
1
Accessory Incompatible
1
1
Break
1
1
Contamination
1
1
Failure to Advance
1
1
Defective Device
1
1
Patient-Device Incompatibility
1
1
Detachment of Device or Device Component
1
1
Microbial Contamination of Device
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Installation-Related Problem
1
1
Positioning Problem
1
1
Radiation Overexposure
1
1
Material Deformation
1
1
Appropriate Term/Code Not Available
1
1
Component Misassembled
1
1
Unclear Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
97
97
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
Insufficient Information
2
2
Cerebral Edema
2
2
Unintended Radiation Exposure
1
1
Urinary Incontinence
1
1
Ambulation Difficulties
1
1
Pain
1
1
Urinary Retention
1
1
Arthralgia
1
1
Death
1
1
Dyspnea
1
1
Incontinence
1
1
Unspecified Infection
1
1
Inflammation
1
1
Myocardial Infarction
1
1
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