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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 955
Human-Device Interface Issue 290
Difficult to remove 108
Increased sensitivity 51
Device operates differently than expected 31
Leak 24
Sticking 17
No Information 17
Failure to Adhere or Bond 15
Material disintegration 9
Defective item 9
Material fragmentation 8
Patient-device incompatibility 7
Device abrasion from instrument or another object 6
No code available 6
Material integrity issue 4
Material separation 4
Size incorrect for patient 3
Wrinkled 3
Melted 3
Foreign material present in device 3
Flare or flash 2
Material deformation 2
Device handling issue 2
Material rigid or stiff 2
Material discolored 2
Fluid leak 2
Delamination 2
Device markings issue 1
Expulsion 1
Slippage of device or device component 1
Buckled material 1
Malposition of device 1
Folded 1
Unable to confirm conditions of use 1
Fitting problem 1
Incomplete or missing packaging 1
Device Issue 1
Blockage within device or device component 1
Loss of or failure to bond 1
Degraded 1
Moisture damage 1
Occlusion within device 1
Difficult to position 1
User used incorrect product for intended use 1
Product quality issue 1
Reflux within device 1
Scratched material 1
Gas leak 1
Improper chemical reaction 1
Incompatibility problem 1
Total Device Problems 1610

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