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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
2017 9 9
2018 71 71
2019 16 16
2020 13 13
2021 11 11
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 68 68
Break 21 21
Material Separation 10 10
Defective Component 3 3
Detachment Of Device Component 2 2
Defective Device 2 2
Appropriate Term/Code Not Available 2 2
Migration 2 2
Device Or Device Fragments Location Unknown 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Device Markings/Labelling Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Insufficient Information 1 1
Component Falling 1 1
Contamination 1 1
Crack 1 1
Migration or Expulsion of Device 1 1
Delivered as Unsterile Product 1 1
Split 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 32 32
Pain 18 18
No Consequences Or Impact To Patient 15 15
Blood Loss 13 13
No Clinical Signs, Symptoms or Conditions 12 12
Unspecified Infection 12 12
No Known Impact Or Consequence To Patient 10 10
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
No Patient Involvement 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
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
Failure of Implant 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 Information 1 1
Hematuria 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medical Action Industries, Inc. 306 II Jun-24-2021
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