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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter and tube, suprapubic
Product CodeFEZ
Regulation Number 876.5090
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 3 3
2022 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Perforation 2 2
Hematuria 2 2
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Abdominal Pain 1 1
Cardiac Arrest 1 1
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LABORIE MEDICAL TECHNOLOGIES, CANADA ULC II Jul-08-2020
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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