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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
2019 16 16
2020 13 13
2021 11 11
2022 10 10
2023 15 15
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Material Separation 22 22
Adverse Event Without Identified Device or Use Problem 9 9
Unsealed Device Packaging 3 3
Defective Component 3 3
Insufficient Information 2 2
Contamination 2 2
Delivered as Unsterile Product 2 2
Leak/Splash 1 1
Crack 1 1
Device Markings/Labelling Problem 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Use of Device Problem 1 1
Packaging Problem 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Migration 1 1
Appropriate Term/Code Not Available 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 6 6
Pain 5 5
Foreign Body In Patient 4 4
Obstruction/Occlusion 3 3
Hemorrhage/Bleeding 3 3
Failure of Implant 2 2
Not Applicable 2 2
Blood Loss 2 2
Post Operative Wound Infection 2 2
Injury 2 2
Insufficient Information 2 2
Bacterial Infection 2 2
Fistula 2 2
Unspecified Infection 1 1
Menstrual Irregularities 1 1
Gastrointestinal Hemorrhage 1 1
Hematoma 1 1
Perforation 1 1
Purulent Discharge 1 1
Edema 1 1
Incontinence 1 1
No Patient Involvement 1 1
Laceration(s) 1 1
Failure to Anastomose 1 1
Abscess 1 1
Calcium Deposits/Calcification 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Erosion 1 1
Pocket Erosion 1 1
Urinary Tract Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
2 Medical Action Industries, Inc. 306 II Dec-22-2022
3 Medical Action Industries, Inc. 306 II Jun-24-2021
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