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 instrument, surgical, disposable
Product CodeKDC
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
-
-