Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device source, brachytherapy, radionuclide
Product CodeKXK
Regulation Number 892.5730
Device Class 2


Premarket Reviews
ManufacturerDecision
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

-
-