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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
2019 16 16
2020 13 13
2021 11 11
2022 10 10
2023 15 15
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Material Separation 18 18
Adverse Event Without Identified Device or Use Problem 9 9
Unsealed Device Packaging 3 3
Defective Component 3 3
Delivered as Unsterile Product 2 2
Contamination 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Migration 1 1
Use of Device Problem 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Crack 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 6 6
Pain 5 5
Hemorrhage/Bleeding 3 3
Obstruction/Occlusion 3 3
Post Operative Wound Infection 2 2
Blood Loss 2 2
Not Applicable 2 2
Injury 2 2
Foreign Body In Patient 2 2
Insufficient Information 2 2
Failure of Implant 2 2
Bacterial Infection 2 2
Fistula 2 2
Hematoma 1 1
Failure to Anastomose 1 1
Abscess 1 1
Erosion 1 1
Calcium Deposits/Calcification 1 1
Purulent Discharge 1 1
Edema 1 1
Incontinence 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Menstrual Irregularities 1 1
Perforation 1 1
Pocket Erosion 1 1
Urinary Tract Infection 1 1
Perforation of Vessels 1 1
Gastrointestinal Hemorrhage 1 1
Unspecified Tissue Injury 1 1
No Patient Involvement 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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