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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 1018
Human-Device Interface Issue 290
Difficult to remove 145
Increased sensitivity 51
Device operates differently than expected 35
Leak 24
Sticking 19
No Information 17
Failure to Adhere or Bond 15
Material disintegration 10
Defective item 9
Material fragmentation 8
Patient-device incompatibility 7
Device abrasion from instrument or another object 6
No code available 6
Device handling issue 6
Foreign material present in device 4
Material integrity issue 4
Material rigid or stiff 4
Material separation 4
Size incorrect for patient 3
Fluid leak 3
Melted 3
Delamination 3
Wrinkled 3
Material deformation 3
Use of Device Issue 2
Expulsion 2
Flare or flash 2
Material discolored 2
Blockage within device or device component 1
Loss of or failure to bond 1
Degraded 1
Slippage of device or device component 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
Device markings issue 1
Buckled material 1
Fitting problem 1
Incomplete or missing packaging 1
Device Issue 1
Malposition of device 1
Folded 1
Unable to confirm conditions of use 1
Scratched material 1
Gas leak 1
Improper chemical reaction 1
Incompatibility problem 1
Total Device Problems 1730

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