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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device irrigator, ostomy
Product CodeEXD
Regulation Number 876.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 3 3
2016 1 1
2018 30 30
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 29 29
Device Contamination with Chemical or Other Material 2 2
Leak/Splash 1 1
Migration or Expulsion of Device 1 1
Torn Material 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Fluid/Blood Leak 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 26 26
No Known Impact Or Consequence To Patient 3 3
No Patient Involvement 3 3
No Code Available 2 2
Unspecified Infection 1 1
Skin Irritation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Fever 1 1

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