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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bag, urinary, ileostomy
Regulation Description Ostomy pouch and accessories.
Product CodeEXH
Regulation Number 876.5900
Device Class 1

Device Problems
No Known Device Problem 36
Occlusion within device 22
No code available 11
Human-Device Interface Issue 9
No flow 8
Deflation issue 7
Difficult to remove 4
Device operates differently than expected 3
Fluid leak 2
Leak 2
Blocked connection 2
Connection issue 2
Increased sensitivity 2
Defective item 1
Reflux within device 1
Failure to Adhere or Bond 1
Loss of or failure to bond 1
Break 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Defective component 1
Total Device Problems 118

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