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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device protector, ostomy
Regulation Description Ostomy pouch and accessories.
Product CodeEXE
Regulation Number 876.5900
Device Class 1

Device Problems
No Known Device Problem 943
Human-Device Interface Issue 290
Difficult to remove 102
Increased sensitivity 51
Device operates differently than expected 30
Leak 24
Sticking 17
No Information 17
Failure to Adhere or Bond 15
Defective item 9
Material fragmentation 8
Material disintegration 7
Patient-device incompatibility 7
Device abrasion from instrument or another object 6
No code available 6
Material integrity issue 4
Material separation 4
Foreign material present in device 3
Size incorrect for patient 3
Wrinkled 3
Melted 3
Delamination 2
Material discolored 2
Flare or flash 2
Material deformation 2
Device handling issue 2
Fluid leak 2
Difficult to position 1
Slippage of device or device component 1
Moisture damage 1
Malposition of device 1
Device markings issue 1
Improper chemical reaction 1
Scratched material 1
User used incorrect product for intended use 1
Material rigid or stiff 1
Incomplete or missing packaging 1
Device Issue 1
Folded 1
Expulsion 1
Fitting problem 1
Blockage within device or device component 1
Reflux within device 1
Incompatibility problem 1
Product quality issue 1
Unable to confirm conditions of use 1
Gas leak 1
Loss of or failure to bond 1
Buckled material 1
Occlusion within device 1
Total Device Problems 1587

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