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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 68 68
Break 19 19
Material Separation 16 16
Detachment Of Device Component 2 2
Defective Component 2 2
Migration 2 2
Appropriate Term/Code Not Available 2 2
Crack 1 1
Use of Device Problem 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Delivered as Unsterile Product 1 1
Connection Problem 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination 1 1
Patient-Device Incompatibility 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 32 32
No Clinical Signs, Symptoms or Conditions 19 19
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
No Code Available 5 5
Injury 5 5
Laceration(s) 4 4
Wound Dehiscence 4 4
Sepsis 4 4
Hematoma 4 4
Inflammation 3 3
Abnormal Vaginal Discharge 3 3
Obstruction/Occlusion 3 3
Fistula 3 3
Premature Labor 3 3
Scar Tissue 2 2
Discomfort 2 2
Miscarriage 2 2
Fever 2 2
Calcium Deposits/Calcification 2 2
Insufficient Information 2 2
Hernia 2 2
Foreign Body In Patient 2 2
Seroma 2 2
Urinary Retention 2 2
Abdominal Pain 2 2
Micturition Urgency 2 2
Urinary Frequency 2 2
Failure to Anastomose 1 1
Menstrual Irregularities 1 1
Septic Shock 1 1
Swelling 1 1
Necrosis 1 1
Death 1 1
Edema 1 1
Foreign Body Reaction 1 1
Uterine Perforation 1 1
Therapeutic Response, Decreased 1 1
Gastrointestinal Hemorrhage 1 1
Unspecified Tissue Injury 1 1
Hematuria 1 1
Rupture 1 1
Cerebrospinal Fluid Leakage 1 1
Abscess 1 1
Failure of Implant 1 1
Perforation 1 1
Skin Irritation 1 1
Pocket Erosion 1 1
Incontinence 1 1
Adhesion(s) 1 1
Purulent Discharge 1 1
Impaired Healing 1 1
No Patient Involvement 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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